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CompletedNCT02127970Updated Sep 28, 2018Results posted

Single Dose vs. Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections

A Phase 3 interventional study of Dalbavancin and Dalbavancin-matching Placebo in Abscess, Wound Infection and Surgical Site Infection, sponsored by Durata Therapeutics Inc., an affiliate of Allergan plc. Completed at 78 sites in 12 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Durata Therapeutics Inc., an affiliate of Allergan plc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
698
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

02

Conditions studied

  • Abscess
  • Wound Infection
  • Surgical Site Infection
  • Cellulitis
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 698 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Durata Therapeutics Inc., an affiliate of Allergan plc is the lead sponsor of 6 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female participants 18 - 85 years of age.
  • Signed and dated informed consent document.
  • Major abscess, surgical site infection, traumatic wound infection or cellulitis suspected or confirmed to be caused by Gram-positive bacteria.
  • At least two (2) local signs and symptoms of acute bacterial skin and skin structure infection (ABSSSI and at least one systemic sign of infection.
  • Participant willing and able to comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • A contra-indication to dalbavancin.
  • Pregnant or nursing females.
  • Sustained shock.
  • Participation in another study of an investigational drug or device within 30 days.
  • Receipt of a systemically or topically administered antibiotic with a Gram-positive spectrum that achieves therapeutic concentrations in the serum or at the site of the ABSSSI within 14 days prior to randomization. An exception is allowed for participants receiving a single dose of a short-acting (half-life ≤ 12 hours) antibacterial drug prior to randomization; up to 25% of participants may have received such therapy.
  • Infection due to an organism known prior to study entry to be resistant to dalbavancin or vancomycin (vancomycin MIC (minimum inhibitory concentration) >8 μg/mL).
  • Evidence of meningitis, necrotizing fasciitis, gas gangrene, gangrene, septic arthritis, osteomyelitis; endovascular infection, such as clinical and/or echocardiographic evidence of endocarditis or septic thrombophlebitis.
  • Infections caused exclusively by Gram-negative bacteria (without Gram-positive bacteria present) and infections caused by fungi, whether alone or in combination with a bacterial pathogen.
  • Venous catheter entry site infection.
  • Infections involving a diabetic foot ulceration, perirectal abscess or a decubitus ulcer.
  • Participant with an infected device, even if the device is removed. Examples include infection of: prosthetic cardiac valve, vascular graft, a pacemaker battery pack, joint prosthesis, hemodialysis catheter, implantable pacemaker or defibrillator, intra-aortic balloon pump, left ventricular assist device, a peritoneal dialysis catheter, or a neurosurgical device such as a ventricular peritoneal shunt, intra-cranial pressure monitor, or epidural catheter.
  • Gram-negative bacteremia, even in the presence of Gram-positive infection or Gram-positive bacteremia. Note: If a Gram-negative bacteremia develops during the study, or is subsequently found to have been present at Baseline, the participant should be removed from study treatment and receive appropriate antibiotic(s) to treat the Gram-negative bacteremia. Such participants must have an end of treatment (EOT) visit performed within 3 calendar days after discontinuing study medication but are required to have AEs (adverse events) reported through the Final Visit.
  • Participants whose ABSSSI is the result of having sustained full or partial thickness burns.
  • Participants with an infection involving a limb with evidence of critical ischemia of an affected limb defined as any of the following criteria: absent or abnormal Doppler wave forms, toe blood pressure of \<45 mm Hg, ankle brachial index \<0.5, and/ or critical ischemia as assessed by a vascular surgeon.
  • Participants with ABSSSI such as superficial/simple cellulitis/erysipelas, impetiginous lesion, furuncle, or simple abscess that only requires surgical drainage for cure.
  • Concomitant condition requiring any antibiotic therapy that would interfere with the assessment of study drug for the condition under study.
  • Anticipated need of antibiotic therapy for longer than 14 days.
  • Participants who are placed in a hyperbaric chamber as adjunctive therapy for the ABSSSI.
  • More than 2 surgical interventions (defined as procedures conducted under sterile technique and typically unable to be performed at the bedside) for the ABSSSI, or participants who are expected to require more than 2 such interventions.
  • Medical conditions in which chronic inflammation may preclude assessment of clinical response to therapy even after successful treatment (e.g., chronic stasis dermatitis of the lower extremity).
  • Absolute neutrophil count \<500 cells/mm\^3.
  • Known or suspected human immunodeficiency virus (HIV) infected participants with a CD4 (cluster of differentiation 4) cell count \<200 cells/mm3 or with a past or current acquired immunodeficiency syndrome (AIDS)-defining condition and unknown CD4 count.
  • Participants with a recent bone marrow transplant (in post-transplant hospital stay).
  • Participants receiving oral steroids >20 mg prednisolone per day (or equivalent) or receiving immunosuppressant drugs after organ transplantation.
  • Participants with a rapidly fatal illness, who are not expected to survive for 3 months.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participants inappropriate for entry into this study.
  • Prior participation in this study.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
698 participants (actual)

Study arms

  • Experimental
    Single-Dose Dalbavancin

    Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg.

    Drug: Dalbavancin · Drug: Dalbavancin-matching Placebo

  • Experimental
    Two-Dose Dalbavancin

    Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.

    Drug: Dalbavancin

Interventions

  • DrugDalbavancin

    Dalbavancin IV infusion over 30 minutes.

    Also known as: DALVANCE®

  • DrugDalbavancin-matching Placebo

    Dalbavancin-matching placebo IV infusion over 30 minutes.

06

What researchers measure

Primary outcomes

  1. Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug

    Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.

    Time frame: Up to 48-72 hours after the initiation of study drug

Secondary outcomes

  1. Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)

    Clinical Success is defined as follows: For evaluation at EOT visit, lesion area must be decreased by ≥80% from baseline and at FV lesion area must be decreased by ≥90% from baseline; Temperature is ≤37.6°C; Local signs of tenderness to palpation and swelling/induration are no worse than mild; For evaluation at EOT visit, local signs of fluctuance and localized heat/warmth must be improved from baseline and no worse than mild, and at FV local signs of fluctuance and localized heat/warmth must be absent; for participants with a wound infection the severity of purulent drainage is improved and no worse than mild relative to baseline. Clinical Failure is defined as the opposite to success or if the participant died during the study period up to visit or received study therapy for ABSSSI beyond the protocol treatment period. Clinical status is Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.

    Time frame: End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)

Other outcomes

  1. Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)

    Clinical Success was defined as localized fluctuance and heat/warmth that if present at Baseline must be improved and no worse than mild. Clinical Failure was defined as the opposite to success. Clinical status was Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.

    Time frame: EOT (Day 14-15)

  2. Percentage of Participants by Investigator Assessment of Clinical Outcome

    A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given. An unsuccessful outcome was the opposite of successful. An Indeterminate outcome was defined as any of the data needed to determine a successful or unsuccessful outcome were missing.

    Time frame: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)

  3. Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline

    A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given.

    Time frame: Day 3-4 and EOT (Day 14-15)

  4. Percentage of Participants With Complete Resolution of Local Signs of Infection

    Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.

    Time frame: Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)

  5. Change From Baseline in Participant's Assessment of Pain

    Using the Brief Pain Inventory Scale, participants rated their pain "right now" on a scale where: 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.

    Time frame: Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)

  6. Percentage of Participants by Resource Utilization Categories

    Resource Utilization Categories included: Any additional visits (including urgent care), Any additional procedures, Any additional tests, Any home visits or nursing care and Any ER Visits. The percentage of participants in each category is reported.

    Time frame: Final Visit (Day 28 +/- 2 days)

  7. Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response

    The SSTI-C Questionnaire is an 11-item self-reported questionnaire that measures subjective experiences of the participant. One of the items assessed was overall satisfaction with treatment. Participants answered the question: "Overall, how satisfied were you with your antibiotic treatment?" using one of the following responses: Extremely satisfied, Moderately satisfied, Not at all satisfied, Slightly satisfied and Very satisfied. The percentage of participants in each category is reported.

    Time frame: EOT (Day 14-15)

07

Results

Posted Aug 14, 2018

Participant flow

Participant flow — Overall Study
MilestoneSingle-Dose DalbavancinTwo-Dose Dalbavancin
Started349349
Completed323322
Not completed2627
Withdrew: Adverse event21
Withdrew: Death11
Withdrew: Lost to follow-up1414
Withdrew: Reason not specified47
Withdrew: Pregnancy01
Withdrew: Subject withdrew consent53

Outcome measures

PrimaryPercentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug

Clinical responder was defined as a participant who was alive and had received no rescue therapy for acute bacterial skin and skin structure infection (ABSSSI) prior to the 48-72 hour infection site assessment (if an antibiotic has been given for another reason, the participant will not be considered a non-responder for this reason); and examination of the participant's ABSSSI lesion demonstrates a decrease of ≥ 20% in lesion area (calculated as the longest length multiplied by the longest perpendicular width) relative to the baseline measurement.

Time frame:
Up to 48-72 hours after the initiation of study drug
Reported as:
Number · percentage of participants
Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Percentage of Participants Who Were Clinical Responders 48-72 Hours After the Initiation of Study Drug81.484.2
Statistical analysis
  • Single-Dose Dalbavancin vs Two-Dose Dalbavancin · Difference: -2.9 · 95% CI -8.5 to 2.8For the difference in clinical responder rates (single-dose group minus two dose group), the 95% CI was calculated using the Miettinen and Nurminen method without adjustment.
SecondaryPercentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)

Clinical Success is defined as follows: For evaluation at EOT visit, lesion area must be decreased by ≥80% from baseline and at FV lesion area must be decreased by ≥90% from baseline; Temperature is ≤37.6°C; Local signs of tenderness to palpation and swelling/induration are no worse than mild; For evaluation at EOT visit, local signs of fluctuance and localized heat/warmth must be improved from baseline and no worse than mild, and at FV local signs of fluctuance and localized heat/warmth must be absent; for participants with a wound infection the severity of purulent drainage is improved and no worse than mild relative to baseline. Clinical Failure is defined as the opposite to success or if the participant died during the study period up to visit or received study therapy for ABSSSI beyond the protocol treatment period. Clinical status is Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.

Time frame:
End of Treatment (Day 14-15 after the initiation of study drug) and Final Visit (28 ±2 days after the initiation of study drug)
Reported as:
Number · percentage of participants
Percentage of Participants by Clinical Status at End of Treatment (EOT) and Final Visit (FV)
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
EOT; Clinical Success84.084.8
EOT; Clinical Failure12.010.3
EOT; Indeterminate4.04.9
FV; Clinical Success84.585.1
FV; Clinical Failure8.07.2
FV; Indeterminate7.47.3
Other pre-specifiedPercentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)

Clinical Success was defined as localized fluctuance and heat/warmth that if present at Baseline must be improved and no worse than mild. Clinical Failure was defined as the opposite to success. Clinical status was Indeterminate if any of the data needed to determine clinical success or clinical failure were missing.

Time frame:
EOT (Day 14-15)
Reported as:
Number · percentage of participants
Percentage of Participants by Clinical Status Based on Localized Fluctuance and Heat/Warmth at End of Treatment (EOT)
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Clinical Success84.885.4
Clinical Failure7.76.9
Indeterminate7.47.7
Other pre-specifiedPercentage of Participants by Investigator Assessment of Clinical Outcome

A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given. An unsuccessful outcome was the opposite of successful. An Indeterminate outcome was defined as any of the data needed to determine a successful or unsuccessful outcome were missing.

Time frame:
Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)
Reported as:
Number · percentage of participants
Percentage of Participants by Investigator Assessment of Clinical Outcome
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Successful Outcome (Day 3-4)93.493.0
Unsuccessful Outcome (Day 3-4)0.30.9
Indeterminate (Day 3-4)6.36.1
Successful Outcome (Day 8)92.293.3
Unsuccessful Outcome (Day 8)0.60.3
Indeterminate (Day 8)7.26.4
Successful Outcome (EOT)92.592.7
Unsuccessful Outcome (EOT)2.91.5
Indeterminate (EOT)4.65.8
Successful Outcome (Final Visit)90.291.0
Unsuccessful Outcome (Final Visit)2.61.7
Indeterminate (Final Visit)7.27.3
Other pre-specifiedPercentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline

A successful outcome was based on resolution or improvement of all signs and symptoms of the infection to such an extent that no further antibacterial treatment was given.

Time frame:
Day 3-4 and EOT (Day 14-15)
Reported as:
Number · percentage of participants
Percentage of Participants Achieving Clinical Outcome of Success Based on Key Target Pathogen at Baseline
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Staphylococcus aureus (Day 3-4)88.585.3
Streptococcus agalactiae (Day 3-4)100.066.7
Streptococcus anginosus group (Day 3-4)93.9100.0
Streptococcus dysgalactiae (Day 3-4)100.0100.0
Streptococcus pyogenes (Day 3-4)100.081.8
Enterococcus faecalis (Day 3-4)100.080.0
Staphylococcus aureus (EOT)87.891.7
Streptococcus agalactiae (EOT)83.383.3
Streptococcus anginosus group (EOT)81.889.5
Streptococcus dysgalactiae (EOT)100.0100.0
Streptococcus pyogenes (EOT)92.981.8
Enterococcus faecalis (EOT)100.0100.0
Other pre-specifiedPercentage of Participants With Complete Resolution of Local Signs of Infection

Resolution of Local Signs of Infection that include absence of purulence/drainage, erythema, heat/localized warmth, pain/tenderness to palpation, fluctuance, and swelling/induration.

Time frame:
Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 +/- 2 days)
Reported as:
Number · percentage of participants
Percentage of Participants With Complete Resolution of Local Signs of Infection
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Day 3-41.91.5
Day 822.321.1
EOT Visit56.356.2
Final Visit85.889.8
Other pre-specifiedChange From Baseline in Participant's Assessment of Pain

Using the Brief Pain Inventory Scale, participants rated their pain "right now" on a scale where: 0=no pain to 10=pain as bad as you can imagine. A negative change from Baseline indicated improvement.

Time frame:
Baseline (Day 0) to Day 3-4, Day 8, EOT (Day 14-15) and Final Visit (Day 28 + /- 2 days)
Reported as:
Mean · Scores on a scale
Change From Baseline in Participant's Assessment of Pain
Scores on a scaleSingle-Dose DalbavancinTwo-Dose Dalbavancin
Baseline7.7 ± 2.097.8 ± 2.12
Change from Baseline to Day 3-4-3.9 ± 2.46-3.8 ± 2.43
Change from Baseline to Day 8-5.9 ± 2.53-5.8 ± 2.68
Change from Baseline to EOT Visit-6.9 ± 2.37-6.9 ± 2.53
Change from Baseline to Final Visit-7.5 ± 2.19-7.4 ± 2.40
Other pre-specifiedPercentage of Participants by Resource Utilization Categories

Resource Utilization Categories included: Any additional visits (including urgent care), Any additional procedures, Any additional tests, Any home visits or nursing care and Any ER Visits. The percentage of participants in each category is reported.

Time frame:
Final Visit (Day 28 +/- 2 days)
Reported as:
Number · percentage of participants
Percentage of Participants by Resource Utilization Categories
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Any Additional Visits (including Urgent Care)1.20.6
Any Additional Procedures1.51.6
Any Additional Tests1.92.8
Any Home Visits or Home Nursing Care1.51.2
Any ER Visits0.30.9
Other pre-specifiedPercentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response

The SSTI-C Questionnaire is an 11-item self-reported questionnaire that measures subjective experiences of the participant. One of the items assessed was overall satisfaction with treatment. Participants answered the question: "Overall, how satisfied were you with your antibiotic treatment?" using one of the following responses: Extremely satisfied, Moderately satisfied, Not at all satisfied, Slightly satisfied and Very satisfied. The percentage of participants in each category is reported.

Time frame:
EOT (Day 14-15)
Reported as:
Number · percentage of participants
Percentage of Participants by Skin and Soft Tissue Infection-Convenience (SSTI-C) Questionnaire: Overall Satisfaction Response
percentage of participantsSingle-Dose DalbavancinTwo-Dose Dalbavancin
Extremely Satisfied53.656.9
Moderately Satisfied9.57.2
Not at all Satisfied0.90.9
Slightly Satisfied0.30.9
Very Satisfied35.833.7

Adverse events

Collected over Up to 28 Days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Single-Dose Dalbavancin1/349 (0.3%)7/349 (2%)0/349 (0%)
Two-Dose Dalbavancin1/346 (0.3%)5/346 (1.4%)0/346 (0%)
Most frequent serious events
Showing 10 of 14
Most frequent serious events
EventSingle-Dose DalbavancinTwo-Dose Dalbavancin
Skin bacterial infectionInfections and infestations2/3490/346
Clostridium difficile colitisInfections and infestations0/3491/346
Necrotising fasciitisInfections and infestations0/3491/346
Renal failure acuteRenal and urinary disorders0/3491/346
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/3491/346
UrticariaSkin and subcutaneous tissue disorders0/3491/346
Vitreous haemorrhageEye disorders1/3490/346
PneumoniaInfections and infestations1/3490/346
SepsisInfections and infestations1/3490/346
Toxicity to various agentsInjury, poisoning and procedural complications1/3490/346

Baseline characteristics

Intent-to-treat (ITT) Population included all randomized participants.

Age, Continuous
Age, Continuous(years)Single-Dose DalbavancinTwo-Dose DalbavancinTotal
Mean48.0 ± 14.8348.3 ± 14.7448.2 ± 14.78
Sex: Female, Male
Sex: Female, Male(Participants)Single-Dose DalbavancinTwo-Dose DalbavancinTotal
Female145146291
Male204203407
08

Study locations

78 sites
  • 110
    Montgomery, Alabama 36106, United States
  • 103
    Anaheim, California 92804, United States
  • 117
    Long Beach, California 90806, United States
  • 106
    Long Beach, California 90813, United States
  • 118
    Modesto, California 95350, United States
  • 104
    San Diego, California 92120, United States
  • 113
    San Diego, California 92120, United States
  • 115
    San Diego, California 92120, United States
  • 116
    San Diego, California 92120, United States
  • 108
    Stockton, California 95204, United States
  • 105
    Sylmar, California 91342, United States
  • 112
    Washington, District of Columbia 20037, United States
  • 107
    Orlando, Florida 32806, United States
  • 120
    Saint Cloud, Florida 34769, United States
  • 114
    Augusta, Georgia 30909, United States
  • 122
    Columbus, Georgia 31904, United States
  • 125
    Savannah, Georgia 31405, United States
  • 119
    Eunice, Louisiana 70535, United States
  • 101
    Springfield, Massachusetts 01199, United States
  • 109
    Detroit, Michigan 48202, United States
  • 121
    Butte, Montana 59701, United States
  • 123
    Omaha, Nebraska 68131, United States
  • 111
    Toledo, Ohio 43608, United States
  • 126
    Franklin, Tennessee 37064, United States
  • 127
    Smyrna, Tennessee 37167, United States
  • 802
    Sofia, 1000, Bulgaria
  • 800
    Sofia, 1431, Bulgaria
  • 801
    Sofia, 1606, Bulgaria
  • 200
    Zagreb, 10000, Croatia
  • 201
    Zagreb, 10000, Croatia
  • 253
    Tallinn, 10318, Estonia
  • 252
    Tallinn, 13419, Estonia
  • 251
    Tartu, 51014, Estonia
  • 302
    Kutaisi, 4600, Georgia
  • 303
    Tbilisi, 0144, Georgia
  • 300
    Tbilisi, 0160, Georgia
  • 301
    Tbilisi, 0160, Georgia
  • 352
    Debrecen, 4012, Hungary
  • 353
    Kaposvar, 7400, Hungary
  • 354
    Pecs, 7632, Hungary
  • 351
    Szeged, 6720, Hungary
  • 402
    Daugavpils, LV-5417, Latvia
  • 401
    Liepaja, LV-3414, Latvia
  • 403
    Rezekne, LV-4601, Latvia
  • 400
    Riga, LV-1002, Latvia
  • 404
    Riga, LV-1038, Latvia
  • 501
    Cluj-Napoca, Cluj County 400006, Romania
  • 502
    Bucharest, 030303, Romania
  • 500
    Bucharest, 041915, Romania
  • 503
    Bucharest, 42122, Romania
  • 555
    Vsevolozhsk, Leningrad Region 188643, Russian Federation
  • 557
    Irkutsk, 664079, Russian Federation
  • 552
    Moscow, 111539, Russian Federation
  • 554
    Moscow, 111539, Russian Federation
  • 553
    Novosibirsk, 630051, Russian Federation
  • 551
    St. Petersburg, 198099, Russian Federation
  • 556
    Tomsk, 634063, Russian Federation
  • 600
    Belgrade, 11000, Serbia
  • 601
    Belgrade, 11000, Serbia
  • 603
    Nis, 18000, Serbia
  • 602
    Novi Sad, 21000, Serbia
  • 756
    Breyten, 2330, South Africa
  • 760
    Cape Town, 7530, South Africa
  • 752
    Dundee, 3000, South Africa
  • 755
    Johannesburg, 2113, South Africa
  • 751
    Middleburg, 1055, South Africa
  • 758
    Port Elizabeth, 6014, South Africa
  • 757
    Pretoria, 0040, South Africa
  • 753
    Pretoria, 0084, South Africa
  • 759
    Pretoria, 0183, South Africa
  • 754
    Worcester, 6850, South Africa
  • 700
    Cherkasy, 18009, Ukraine
  • 704
    Dnipropetrovsk, 49005, Ukraine
  • 706
    Ivano-Frankivsk, 76012, Ukraine
  • 701
    Ivano-Frankivsk, 76025, Ukraine
  • 705
    Kharkiv, 61037, Ukraine
  • 703
    Lviv, 79059, Ukraine
  • 702
    Zaporizhzhya, 69032, Ukraine
09

References and documents

Publications

  • Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14. PubMed 34905144 ↗
  • Rappo U, Gonzalez PL, Puttagunta S, Akinapelli K, Keyloun K, Gillard P, Liu Y, Dunne MW. Single-dose dalbavancin and patient satisfaction in an outpatient setting in the treatment of acute bacterial skin and skin structure infections. J Glob Antimicrob Resist. 2019 Jun;17:60-65. doi: 10.1016/j.jgar.2019.02.007. Epub 2019 Feb 20. PubMed 30797084 ↗
  • Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis. 2016 Mar 1;62(5):545-51. doi: 10.1093/cid/civ982. Epub 2015 Nov 26. PubMed 26611777 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02127970
Lead sponsor
Durata Therapeutics Inc., an affiliate of Allergan plc
Responsible party
Sponsor
First posted
May 1, 2014
Start date
Apr 18, 2014
Primary completion
Mar 11, 2015
Completion
Mar 11, 2015
Results posted
Aug 14, 2018
Last update
Sep 28, 2018

Study contacts

Urania Rappo, MD
study director · Allergan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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Durata Therapeutics Inc., an affiliate of Allergan plc

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