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CompletedNCT03959527Updated Oct 8, 2025Results posted

Zoliflodacin in Uncomplicated Gonorrhoea

A Phase 3 interventional study of zoliflodacin and ceftriaxone in Gonorrhea, sponsored by Global Antibiotics Research and Development Partnership. Completed at 17 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.

Sponsored by Global Antibiotics Research and Development Partnership · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,011
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.

02

Conditions studied

  • Gonorrhea

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03

In context

Gonorrhea

155 studies on the registry are indexed under Gonorrhea; 26 are open to participants now.

This study's enrollment of 1,011 is above the median of 360 across 117 interventional studies indexed under Gonorrhea.

Browse Gonorrhea studies →

Lead sponsor

Global Antibiotics Research and Development Partnership is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)
  2. Weight ≥ 35 kg
  3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)
  4. For females of child-bearing potential, a negative urine pregnancy test at screening
  5. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.
  6. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment
  7. Willingness to comply with trial protocol
  8. Willingness to undergo HIV testing
  9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit
  10. Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate).

Exclusion criteria

Exclusion Criteria:

  1. Confirmed or suspected complicated or disseminated gonorrhoea
  2. Pregnant or breastfeeding women
  3. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)
  4. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening
  5. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening
  6. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening
  7. Cytotoxic or radiation therapy within 30 days prior to screening
  8. Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination
  9. History of urogenital sex-reassignment surgery
  10. Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count \<200 cells/μL
  11. Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation
  12. Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics
  13. Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments)
  14. Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial
  15. History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator
  16. Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent
  17. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol
  18. Previous randomisation in this clinical trial.
  19. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,011 participants (actual)

Study arms

  • Experimental
    zoliflodacin

    Participant in this arm will receive a single dose of zoliflodacin.

    Drug: zoliflodacin

  • Active comparator
    ceftriaxone and azithromycin combination

    Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).

    Drug: ceftriaxone · Drug: azithromycin

Interventions

  • Drugzoliflodacin

    Dose: 3g, oral administration

  • Drugceftriaxone

    Dose: 500mg, Intra-Muscular (IM) administration

  • Drugazithromycin

    Dose: 1g, oral administration

06

What researchers measure

Primary outcomes

  1. Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set

    Time frame: Day 6 (+/- 2)

Secondary outcomes

  1. Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.

    Incidence, severity, causality and seriousness of treatment-emergent adverse events (including clinically significant abnormal laboratory values/procedures i.e., physical examination per protocol)

    Time frame: Day 30

  2. Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with microbiological cure as determined by NG culture at pharyngeal sites at test of cure visit in micro-ITT (Pharyngeal).

    Time frame: Day 6

  3. Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with microbiological cure as determined by NG culture at rectal sites at test of cure visit in micro-ITT (Rectal).

    Time frame: Day 6

  4. The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of male at birth participants experiencing resolution of signs and symptoms of urogenital gonococcal infection that were present at enrolment, at test of cure visit in Clinical Cure Population.

    Time frame: Day 6

  5. Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin

    Proportion of female participants with microbiological cure, as determined by NG culture at cervical site of infection, at TOC in micro-ITT (Urogenital) population

    Time frame: Day 6

  6. Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin

    Proportion of male participants with microbiological cure as determined by NG culture at urethral site of infection at TOC visit, in micro-ITT population

    Time frame: Day 6

  7. Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with a positive NG NAAT result from urethral or cervical sites at baseline and a negative NG NAAT result at test of cure visit in micro-ITT analysis set.

    Time frame: Day 6

  8. Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with a positive NG NAAT at baseline from pharyngeal sites and a negative NG NAAT at test of cure visit in micro-ITT analysis set.

    Time frame: Day 6

  9. Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

    Proportion of participants with a positive NG NAAT from rectal sites at baseline and a negative NG NAAT at test of cure visit in micro-ITT analysis set.

    Time frame: Day 6

  10. Arithmetic Mean Plasma Concentration of Zoliflodacin

    Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following oral administration of single oral dose of zoliflodacin 3 g

    Time frame: 15 min - 1 hour

  11. Arithmetic Mean Plasma Concentration of Zoliflodacin

    Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g

    Time frame: 2-2.5 h

  12. Arithmetic Mean Plasma Concentration of Zoliflodacin

    Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g

    Time frame: 4.5 - 5h

  13. Arithmetic Mean Plasma Concentration of Zoliflodacin

    Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g

    Time frame: 10 -12 h

  14. Arithmetic Mean Plasma Concentration of Zoliflodacin

    Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g

    Time frame: 24 - 36 h

  15. Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin

    Geometric mean time to last (Tlast) plasma concentration above the lower limit of quantitation

    Time frame: Day 2

  16. Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin

    Geometric mean time to maximum plasma concentration (Tmax) after a single, oral, 3 g dose of zoliflodacin

    Time frame: Day 2

  17. Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin

    Geometric mean maximum plasma concentration (Cmax) after a single, oral 3 g dose of zoliflodacin

    Time frame: Day 2

  18. Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin

    Geometric mean plasma area under the concentration-time curve (AUC0-last) from time zero to the last concentration above lower level of quantification

    Time frame: Day 2

  19. Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)

    Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (Day 1)

    Time frame: Day 1

  20. Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.

    Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  21. Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  22. Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.

    Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  23. Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  24. Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.

    Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  25. Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to ciprofloxacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (zoliflodacin arm only since no microbiological failures in comparator arm)

    Time frame: Day 1

  26. Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit

    Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  27. Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  28. Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.

    Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  29. Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  30. Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit

    Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  31. Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  32. Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit

    Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

  33. Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline

    Antimicrobial susceptibility to zolflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

    Time frame: Day 1

  34. Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit

    Antimicrobial susceptibility to zoliflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

    Time frame: Day 6

07

Results

Posted Jul 26, 2024
Limitations and caveats
Relatively low representation of females in primary analysis set due to asymptomatic nature of NG in this population, non-specific symptoms and inclusion criteria (prior contraceptive use). Relatively low representation of adolescents in study and non in PK sub-study, due to challenges with obtaining parental consent primarily in this indication.

Participant flow

Participant flow — Overall Study
MilestoneZoliflodacinCeftriaxone and Azithromycin Combination
Started621309
Completed571285
Not completed5024
Withdrew: Withdrawal by subject83
Withdrew: Lost to follow-up3115
Withdrew: Did not meet eligibility criteria11
Withdrew: Protocol violation105

Outcome measures

PrimaryMicrobiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set

Time frame:
Day 6 (+/- 2)
Reported as:
Number · percentage of participants
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.
percentage of participantsZoliflodacinCeftriaxone and Azithromycin Combination
Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.90.9 (88.1 to 93.3)96.2 (92.9 to 98.3)
Statistical analysis
  • Zoliflodacin vs Ceftriaxone and Azithromycin Combination · Risk difference (rd): 5.31 · 95% CI 1.38 to 8.6595% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin
SecondarySafety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.

Incidence, severity, causality and seriousness of treatment-emergent adverse events (including clinically significant abnormal laboratory values/procedures i.e., physical examination per protocol)

Time frame:
Day 30
Reported as:
Count of participants · Participants
Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
All AEs287144
Related AEs11776
Serious AEs00
AEs leading to treatment discontinuation00
AEs leading to death00
Maximum severity CTCAE Grade 1 or Mild15782
Maximum severity CTCAE Grade 2 or Moderate10944
Maximum severity CTCAE Grade 3 or Severe2018
Maximum severity CTCAE Grade 4 or Life-Threatening10
Maximum severity CTCAE Grade 5 or Death00
SecondaryMicrobiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with microbiological cure as determined by NG culture at pharyngeal sites at test of cure visit in micro-ITT (Pharyngeal).

Time frame:
Day 6
Reported as:
Count of participants · Participants
Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.4222
SecondaryMicrobiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with microbiological cure as determined by NG culture at rectal sites at test of cure visit in micro-ITT (Rectal).

Time frame:
Day 6
Reported as:
Count of participants · Participants
Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.6931
SecondaryThe Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of male at birth participants experiencing resolution of signs and symptoms of urogenital gonococcal infection that were present at enrolment, at test of cure visit in Clinical Cure Population.

Time frame:
Day 6
Reported as:
Count of participants · Participants
The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.375194
SecondaryMicrobiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin

Proportion of female participants with microbiological cure, as determined by NG culture at cervical site of infection, at TOC in micro-ITT (Urogenital) population

Time frame:
Day 6
Reported as:
Count of participants · Participants
Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin4816
SecondaryMicrobiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin

Proportion of male participants with microbiological cure as determined by NG culture at urethral site of infection at TOC visit, in micro-ITT population

Time frame:
Day 6
Reported as:
Count of participants · Participants
Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin412213
SecondaryEradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with a positive NG NAAT result from urethral or cervical sites at baseline and a negative NG NAAT result at test of cure visit in micro-ITT analysis set.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.405190
SecondaryEradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with a positive NG NAAT at baseline from pharyngeal sites and a negative NG NAAT at test of cure visit in micro-ITT analysis set.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.2812
SecondaryEradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.

Proportion of participants with a positive NG NAAT from rectal sites at baseline and a negative NG NAAT at test of cure visit in micro-ITT analysis set.

Time frame:
Day 6
Reported as:
Count of participants · Participants
Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.
ParticipantsZoliflodacinCeftriaxone and Azithromycin Combination
Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.6027
SecondaryArithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following oral administration of single oral dose of zoliflodacin 3 g

Time frame:
15 min - 1 hour
Reported as:
Mean · ng/mL
Arithmetic Mean Plasma Concentration of Zoliflodacin
ng/mLZoliflodacin
Arithmetic Mean Plasma Concentration of Zoliflodacin580 ± 830
SecondaryArithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g

Time frame:
2-2.5 h
Reported as:
Mean · ng/mL
Arithmetic Mean Plasma Concentration of Zoliflodacin
ng/mLZoliflodacin
Arithmetic Mean Plasma Concentration of Zoliflodacin14500 ± 9610
SecondaryArithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g

Time frame:
4.5 - 5h
Reported as:
Mean · ng/mL
Arithmetic Mean Plasma Concentration of Zoliflodacin
ng/mLZoliflodacin
Arithmetic Mean Plasma Concentration of Zoliflodacin32300 ± 8630
SecondaryArithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g

Time frame:
10 -12 h
Reported as:
Mean · ng/mL
Arithmetic Mean Plasma Concentration of Zoliflodacin
ng/mLZoliflodacin
Arithmetic Mean Plasma Concentration of Zoliflodacin19300 ± 6000
SecondaryArithmetic Mean Plasma Concentration of Zoliflodacin

Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g

Time frame:
24 - 36 h
Reported as:
Mean · ng/mL
Arithmetic Mean Plasma Concentration of Zoliflodacin
ng/mLZoliflodacin
Arithmetic Mean Plasma Concentration of Zoliflodacin3270 ± 1560
SecondaryEvaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin

Geometric mean time to last (Tlast) plasma concentration above the lower limit of quantitation

Time frame:
Day 2
Reported as:
Geometric mean · hours
Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin
hoursZoliflodacin
Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin24.6 ± 3.2
SecondaryEvaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin

Geometric mean time to maximum plasma concentration (Tmax) after a single, oral, 3 g dose of zoliflodacin

Time frame:
Day 2
Reported as:
Geometric mean · hours
Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin
hoursZoliflodacin
Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin4.83 ± 41.0
SecondaryEvaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin

Geometric mean maximum plasma concentration (Cmax) after a single, oral 3 g dose of zoliflodacin

Time frame:
Day 2
Reported as:
Geometric mean · ng/mL
Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin
ng/mLZoliflodacin
Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin31800 ± 27.3
SecondaryEvaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin

Geometric mean plasma area under the concentration-time curve (AUC0-last) from time zero to the last concentration above lower level of quantification

Time frame:
Day 2
Reported as:
Geometric mean · h*ng/mL
Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin
h*ng/mLZoliflodacin
Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin330000 ± 26.5
SecondaryAntimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)

Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (Day 1)

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)1 (0.06 to 8)1 (0.06 to 8)
SecondaryAntimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.

Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.0.25 (0.06 to 2)—
SecondaryAntimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline0.06 (0.002 to 0.5)0.06 (0.002 to 0.5)
SecondaryAntimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.

Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.0.015 (0.002 to 0.03)—
SecondaryAntimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline0.015 (0.002 to 0.25)0.015 (0.002 to 0.12)
SecondaryAntimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.

Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.0.015 (0.002 to 0.015)—
SecondaryAntimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to ciprofloxacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (zoliflodacin arm only since no microbiological failures in comparator arm)

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline2 (0.0005 to 2)2 (0.002 to 2)
SecondaryAntimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit

Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit2 (0.004 to 2)—
SecondaryAntimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline8 (1 to 16)8 (0.5 to 16)
SecondaryAntimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.

Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.8 (4 to 8)—
SecondaryAntimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline32 (8 to 64)32 (8 to 64)
SecondaryAntimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit

Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit32 (16 to 32)—
SecondaryAntimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline4 (0.12 to 4)4 (0.12 to 4)
SecondaryAntimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit

Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit4 (0.5 to 4)—
SecondaryAntimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline

Antimicrobial susceptibility to zolflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline

Time frame:
Day 1
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline0.12 (0.008 to 0.5)0.12 (0.008 to 0.25)
SecondaryAntimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit

Antimicrobial susceptibility to zoliflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC

Time frame:
Day 6
Reported as:
Mean · mg/L
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit
mg/LZoliflodacinCeftriaxone Plus Azithromycin Combination
Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit0.12 (0.008 to 0.25)—

Adverse events

Collected over 30 days (+/- 3 days). Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Zoliflodacin0/619 (0%)0/619 (0%)162/619 (26.2%)
Ceftriaxone and Azithromycin Combination0/308 (0%)0/308 (0%)107/308 (34.7%)
Most frequent other events
Most frequent other events
EventZoliflodacinCeftriaxone and Azithromycin Combination
Injection site painGeneral disorders5/61938/308
HeadacheNervous system disorders61/61914/308
NeutropeniaBlood and lymphatic system disorders42/61924/308
DiarrhoeaGastrointestinal disorders15/61922/308
Neutrophil count decreasedInvestigations21/61915/308
NauseaGastrointestinal disorders16/61912/308
LeukopeniaBlood and lymphatic system disorders24/6197/308
DizzinessNervous system disorders21/6195/308

Baseline characteristics

Randomised population

Age, Continuous
Age, Continuous(years)ZoliflodacinCeftriaxone and Azithromycin CombinationTotal
Mean30.0 ± 9.5629.2 ± 9.1329.7 ± 9.42
Sex: Female, Male
Sex: Female, Male(Participants)ZoliflodacinCeftriaxone and Azithromycin CombinationTotal
Female7738115
Male544271815
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ZoliflodacinCeftriaxone and Azithromycin CombinationTotal
Hispanic or Latino181331
Not Hispanic or Latino603296899
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ZoliflodacinCeftriaxone and Azithromycin CombinationTotal
American Indian or Alaska Native819
Asian19392285
Native Hawaiian or Other Pacific Islander213
Black or African American349165514
White6647113
More than one race123
Unknown or Not Reported213
Region of Enrollment
Region of Enrollment(participants)ZoliflodacinCeftriaxone and Azithromycin CombinationTotal
Netherlands492069
Belgium639
United States10751158
South Africa278146424
Thailand18189270
08

Study locations

17 sites
  • Jefferson County Department of Health
    Birmingham, Alabama 35233, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294-0006, United States
  • San Francisco Department Of Public Health City Clinic
    San Francisco, California 94103, United States
  • Bell Flower Clinic
    Indianapolis, Indiana 46202, United States
  • Louisiana State University Health Sciences Center
    New Orleans, Louisiana 70112, United States
  • Public Health - Seattle & King County STD Clinic
    Seattle, Washington 98104, United States
  • Institute of Tropical Medicine
    Antwerp, 2000, Belgium
  • Public Health Service (GGD) Amsterdam / STI Outpatient Clinic
    Amsterdam, 1018 WT, Netherlands
  • SAMRC Botha's Hill Clinical Research Site
    Bothas Hill, 3660, South Africa
  • Masiphumelele Research Site
    Cape Town, 7975, South Africa
  • Ndlovu Research Centre
    Elandsdoorn, 0470, South Africa
  • Wits RHI
    Johannesburg, 2001, South Africa
  • Setshaba Research Centre
    Soshanguve, 0152, South Africa
  • SAMRC Tongaat Clinical Research Site
    Tongaat, 4400, South Africa
  • Bangrak STI Center
    Bangkok, 10120, Thailand
  • Institute of HIV Research and Innovation
    Bangkok, 10330, Thailand
  • Silom Community Clinic
    Bangkok, 10400, Thailand
09

References and documents

Publications

  • Luckey A, Balasegaram M, Barbee LA, Batteiger TA, Broadhurst H, Cohen SE, Delany-Moretlwe S, de Vries HJC, Dionne JA, Gill K, Kenyon C, Kittiyaowamarn R, Lewis D, Mueller JP, Naicker V, O'Brien S, O'Donnell JP, Phanuphak N, Spooner E, Srinivasan S, Taylor SN, Unemo M, Zwane Z, Hook EW 3rd; Zoliflodacin Phase 3 Study Group. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. Lancet. 2026 Jan 10;407(10524):147-160. doi: 10.1016/S0140-6736(25)01953-1. Epub 2025 Dec 11. PubMed 41391465 ↗
  • Jacobsson S, Golparian D, Oxelbark J, Kong FYS, Da Costa RMA, Franceschi F, Brown D, Louie A, Drusano G, Unemo M. Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow-fiber infection model. Front Pharmacol. 2023 Dec 7;14:1291885. doi: 10.3389/fphar.2023.1291885. eCollection 2023. PubMed 38130409 ↗

Study documents

  • Study protocol · Jul 12, 2023
  • Statistical analysis plan · Sep 14, 2023
  • Informed consent form · Oct 26, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03959527
Lead sponsor
Global Antibiotics Research and Development Partnership
Responsible party
Sponsor
First posted
May 22, 2019
Start date
Nov 6, 2019
Primary completion
Aug 30, 2023
Completion
Sep 18, 2023
Results posted
Jul 26, 2024
Last update
Oct 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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