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Not yet recruitingNCT07885891Updated Oct 21, 2026

Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

A Phase 3 interventional study of Cefepime-Zidebactam and Ceftazidime-avibactam with or without Colistin in Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP), sponsored by Wockhardt. Not yet recruiting at 55 sites in 14 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Wockhardt · Phase 3, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
324
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

This is a Phase 3, randomized, double-blind, multicenter, comparative study evaluating cefepime-zidebactam (FEP-ZID) versus ceftazidime-avibactam (CAZ-AVI) with or without colistin in the treatment of adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Trial participants will be randomized in a 1:1 ratio to receive either FEP-ZID or CAZ-AVI with or without colistin for 7 to 14 days. Colistin will be added to the CAZ-AVI regimen (or matching saline to the FEP-ZID regimen, to maintain blinding) for participants with a baseline pathogen presumed or confirmed to be CAZ-AVI-resistant. All trial participants will also receive linezolid for coverage of methicillin-resistant staphylococci for at least the first 3 days of treatment.

The primary objectives are to assess 14-day all-cause mortality between treatment groups and to assess the safety and tolerability of FEP-ZID relative to CAZ-AVI with or without colistin. Secondary objectives include 28-day all-cause mortality, clinical and microbiological outcomes at End-of-Treatment (EOT) and Test-of-Cure (TOC), sustained clinical cure at Late Follow-up (LFU), superinfection and new infection rates, and pharmacokinetic (PK) characterization of FEP and ZID.

02

Conditions studied

  • Hospital Acquired Bacterial Pneumonia (HABP)
  • Ventilator Associated Bacterial Pneumonia (VABP)
03

In context

Lead sponsor

Wockhardt is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Browse Wockhardt studies →

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

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male or female ≥18 years of age.
  2. Provide signed written informed consent prior to any study specific procedures. A legally acceptable representative may provide consent provided this is permitted by national law and ethical considerations as well as institution-specific guidelines (proxy consent). In participants in clinical course compatible with an emergency situation and not able to provide consent while a legally acceptable representative is not available, a deferred consent framework for emergency research may be applied if permitted by national law and ethical considerations as well as institution-specific guidelines.

  3. Have at least one of the following new-onset or worsening signs within 24 hours prior to randomization:

    • Fever (oral, tympanic, temporal, or rectal temperature >38 °C [>100.4 °F])
    • Hypothermia (rectal/core temperature \<35 °C [\<95.2 °F])
    • White blood cell (WBC) count >10,000 cells/mm3
    • WBC count of \<4,500 cells/mm3
    • Bandemia (immature neutrophils) on a WBC count of >15%
  4. Meet ALL the following clinical criteria for either:

A. VABP:

  1. Receiving continuous mechanical ventilation ≥48 hours prior to the onset of signs and symptoms of pneumonia.
  2. New or worsening infiltrate consistent with pneumonia on chest X-ray or chest computed tomography (CT) obtained at least 48 hours after starting mechanical ventilation.
  3. Required acute changes in ventilator support to improve oxygenation with worsening ratio of the partial pressure of oxygen in arterial blood to the inspired oxygen fraction or needed changes in the amount of positive end-expiratory pressure.

B. HABP:

  1. Hospitalized for more than 48 hours prior to the onset of signs and symptoms of pneumonia (or had a prior hospital admission >48 hours if discharged within the last 7 days).
  2. New or worsening infiltrate consistent with pneumonia on X-ray or chest CT obtained at least 48 hours or more after hospital admission.
  3. New onset or acute worsening pulmonary symptoms or signs, such as cough, dyspnea, tachypnea, (e.g., respiratory rate greater than 25 breaths per minute), hypoxemia, expectorated sputum production, and/or requirement for mechanical ventilation.

5. If a female of childbearing potential, must have a negative urine or serum pregnancy test (β-human chorionic gonadotropin) during their hospitalization and must agree to use one of the following highly effective methods of contraception through TOC:

  • Surgical sterilization (defined as bilateral oophorectomy or bilateral salpingectomy, but excluding bilateral tubal occlusion)
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable)
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Sexual intercourse with only vasectomized partners, or
  • Abstinence, defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the trial participant
  • Post-menopausal (as defined in the note below)

Note: a female is considered to be of childbearing potential unless post-menopausal for more than 1 year of spontaneous amenorrhea or permanently surgically sterilized (bilateral oophorectomy, salpingectomy, hysterectomy, tubal ligation). A high follicle stimulation hormone level in the post-menopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy.

6.If male, trial participant must agree to use an acceptable barrier method of birth control (i.e., condom) with female partner(s) of childbearing potential who are using one of the contraceptive methods described above in Inclusion Criterion 5, and must not donate sperm from Screening through TOC.

Exclusion criteria

Exclusion Criteria:

  1. History of serious or significant hypersensitivity or allergic reaction (e.g., anaphylaxis, urticaria, other significant reaction) to any β-lactam antibiotic or to the excipient L-arginine; avibactam or avibactam-containing-product; linezolid; or colistin.
  2. Current pneumonia due to Stenotrophomonas or Burkholderia species identified on culture prior to randomization.
  3. Known or suspected community-acquired, viral, fungal (including Pnuemocystis jirovecii), mycobacterial (including tuberculous), or parasitic pneumonia.
  4. Diagnosed or suspected to have atypical pneumonia (including Legionella pneumophilia) or a positive test result on the BPP for an atypical organism.
  5. Current pneumonia known or suspected to be caused by an organism that is resistant to FEP-ZID or to both CAZ-AVI and colistin.
  6. Diagnosed with COVID-19 or positive test for SARS-CoV-2 virus within the past 2 weeks.

  7. Any of the following conditions or diagnoses:

    • Cystic fibrosis or similar conditions (e.g., non-cystic fibrosis bronchiectasis)
    • Lung abscess
    • Pleural empyema
    • Lung cancer or metastases to the lungs or other known causes of pulmonary obstruction
    • Penetrating chest trauma
    • Definitive diagnosis of aspiration pneumonia
    • Any other infection outside of the lung that requires systemic antibacterial therapy
  8. Current treatment with a monoamine oxidase inhibitor (MAOI) or having received a MAOI within the past 2 weeks prior to randomization, or need for such treatment during the study treatment period.
  9. Current receipt of curariform muscle relaxants (e.g., tubocurarine) or other drugs potentiating the neuromuscular blocking effect (e.g., ether, succinylcholine, gallamine, decamethonium and sodium citrate), or need for such treatment during the study treatment period.
  10. Receipt of CAZ-AVI or FEP-ZID within 30 days prior to enrolment for treatment of any infection.

  11. Receipt of potentially effective systemic or inhaled antibacterial therapy for more than 48 hours within 72 hours prior to randomization, with the exception of either of the following:

    • Receipt of >48 hours of prior antibiotic therapy and in the investigator's opinion, failed that prior antibiotic therapy (i.e., worsening signs and symptoms) or
    • Documented to have a gram-negative pathogen that is non-susceptible to the prior therapy administered for the pneumonia
  12. Pneumonia caused by sole gram-positive pathogen(s) if known based on culture report or BPP result.
  13. Expected survival \<72 hours or having a "do not resuscitate" order or any life-threatening condition other than index pneumonia, due to which the trial participant is likely not to survive the study period.
  14. APACHE II score of >30.
  15. History of epilepsy or seizure disorder requiring current treatment with anti-seizure medication.
  16. Women who are pregnant or nursing.
  17. Participants CRRT (e.g., continuous venovenous hemofiltration, continuous venovenous hemodialysis, or continuous venovenous hemodiafiltration) as there is no available data on dosing of FEP-ZID for those on CRRT at this time.

  18. Participants with a CrCl \<15 mL/min will be included with the exception of:

    • Those on intermittent renal replacement therapy for a period shorter than 4 months prior to randomization
    • Diagnosis of acute kidney injury at study screening or randomization
  19. Screening serum total bilirubin >2 times the upper limit of normal (unless elevated indirect bilirubin due to known Gilbert's syndrome), or alanine aminotransferase ≥5 × upper limit of normal, or known to meet Child-Pugh class C criteria for liver insufficiency.
  20. On extracorporeal membrane oxygenation (ECMO) or expected to receive ECMO within 72 hours.
  21. Current neutropenia defined as \<500 neutrophils/ mm3, or platelet count \<50,000 per mL.
  22. Have received solid organ, stem cell, bone marrow transplant or had splenectomy.
  23. History of Clostridioides difficile-associated disease within 6 months prior to enrolment.
  24. Prior randomization in this study at any point, or use of any experimental drug or device within 30 days or 5 half-lives prior to enrollment.
  25. Has any condition or clinically significant abnormality or emergent surgery that, in the opinion of the investigator, is likely to interfere with optimal study participation, might confound the results of the study, or pose additional risk to the trial participant.
  26. Employed by the sponsor, investigator, or investigational site or is a first degree relative or spouse of a person employed by the sponsor or investigational site.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
324 participants (estimated)

Study arms

  • Experimental
    Cefepime-Zidebactam

    Drug: Cefepime-Zidebactam

  • Active comparator
    Ceftazidime-avibactam with or without Colistin

    Drug: Ceftazidime-avibactam with or without Colistin

Interventions

  • DrugCefepime-Zidebactam

    3 g (2 g FEP + 1 g ZID) IV every 8 hours (q8h), infused over 60 ± 5 minutes for 7 to 14 days

  • DrugCeftazidime-avibactam with or without Colistin

    CAZ-AVI 2.5 g (2 g CAZ + 0.5 g AVI) IV q8h, infused as 2 infusion bags, each bag infused over 60 ± 5 minutes for 7 to 14 days, with or without colistin (loading dose 300 mg IV CBA infused over 60 ± 5 minutes, followed by 180 mg IV CBA q12h) for participants with a CAZ-AVI-resistant baseline pathogen

06

What researchers measure

Primary outcomes

  1. All-cause mortality at 14 days

    All-cause mortality at 14 days defined as death for any reason up to and including Day 14 in the Modified Intent-to-Treat (MITT) analyses set. Each trial participant is expected to complete the study through the LFU visit (the latter to also be performed for participants who prematurely discontinued the study treatment). * Inter-current events (not necessarily mutually exclusive) will be handled as follows: * Participants receiving any alternative non-study systemic antibacterial started post-randomization for the treatment of the HABP/VABP before (and including) Day 14 will be evaluated for mortality as observed on study Day 14 (treatment policy strategy). * Participants with early treatment and/or study discontinuation prior to Day 14 will be followed and evaluated for mortality as observed on Day 14 (treatment policy strategy) * Handling of missing data: * Participants for whom the survival status at Day 14 is unknown for whatever reason will be presumed to be non-survivors.

    Time frame: Day 14

Secondary outcomes

  1. All-cause mortality at 28 days

    All-cause mortality at 28 days defined as death for any reason up to and including Day 28 in the MITT analyses set. * Inter-current events (not necessarily mutually exclusive) will be handled as follows: * Participants receiving any alternative non-study systemic antibacterial started post-randomization for the treatment of the HABP/VABP before (and including) Day 28 will be evaluated for mortality as observed on study Day 28 (treatment policy strategy). * Participants with early treatment and/or study discontinuation prior to Day 28 will be followed and evaluated for mortality as observed on Day 28 (treatment policy strategy) * Handling of missing data ▪ Participants for whom the survival status at Day 28 is unknown for whatever reason, will be presumed to be non-survivors.

    Time frame: Day 28

  2. Clinical Outcome at EOT in the MITT analyses set

    Clinical response: improvement in signs and symptoms such that no additional antibacterial therapy is required for the treatment of the pneumonia. Clinical non-response (any of the following): worsening or no improvement of HABP/VABP signs and symptoms requiring additional non-study systemic antibacterial therapy started post-randomization, except antibiotics with sole gram-positive activity; requiring more than 14 days of antibacterial therapy for HABP/VABP; death from any cause by the time of the assessment; discontinuation of study therapy due to a TEAE AND alternative antibacterial therapy is required, except agents with sole gram-positive coverage. Indeterminate: clinical outcome data missing for any reason. Intercurrent events are handled as part of the definition of clinical non-response. Participants with missing data will have an indeterminate outcome.

    Time frame: EOT (Days 7 to 14)

  3. Clinical Outcome at TOC in the MITT analyses set

    * Clinical cure - continued improvement in signs and symptoms such that no antibacterial therapy is required for the treatment of the pneumonia after EOT. * Clinical failure * Recurrence of any of the pneumonia-associated signs and symptoms that were present before EOT, * Development of new signs and symptoms of HABP/VABP requiring additional and/or alternative non-study systemic antibacterial therapy, * Death from any cause, * Clinical non-response at EOT will be carried forward to the TOC visit as a clinical failure. Indeterminate - study data for the determination of the clinical outcome at TOC are missing for any reason. Intercurrent events (as detailed in Section 15.4.3.2) are handled as part of the definition of clinical non-response (composite variable strategy). Participants with missing data will have an indeterminate outcome.

    Time frame: TOC (Day 21± 2 days)

  4. Number of Participants with Sustained clinical cure at LFU in the MITT Population

    Sustained clinical cure is a single composite outcome assessed once per participant. A participant is classified as having sustained clinical cure if they had clinical cure at Test-of-Cure (TOC) and, at LFU, had no new signs or symptoms of pneumonia requiring additional antibacterial therapy and had not died from any cause. These criteria define one classification and are not separate outcomes. Participants whose LFU outcome cannot be evaluated because of missing data are classified as indeterminate. The reported value is the number of participants with sustained clinical cure.

    Time frame: Day 35 ± 5 days

  5. Number of Participants with Sustained Clinical Cure at LFU in the mMITT Population

    Sustained clinical cure is a single composite outcome assessed once per participant. A participant is classified as having sustained clinical cure if they had clinical cure at Test-of-Cure (TOC) and, at LFU, had no new signs or symptoms of pneumonia requiring additional antibacterial therapy and had not died from any cause. These criteria define one classification and are not separate outcomes. Participants whose LFU outcome cannot be evaluated because of missing data are classified as indeterminate. The reported value is the number of participants with sustained clinical cure.

    Time frame: Day 35 ± 5 days

  6. Number of Participants with Sustained Clinical Cure at LFU in the CE Population

    Sustained clinical cure is a single composite outcome assessed once per participant. A participant is classified as having sustained clinical cure if they had clinical cure at Test-of-Cure (TOC) and, at LFU, had no new signs or symptoms of pneumonia requiring additional antibacterial therapy and had not died from any cause. These criteria define one classification and are not separate outcomes. Participants whose LFU outcome cannot be evaluated because of missing data are classified as indeterminate. The reported value is the number of participants with sustained clinical cure.

    Time frame: Day 35 ± 5 days

  7. Microbiological Response in the mMITT analyses set

    Overall by-subject response, based on per-pathogen microbiological outcome at EOT and TOC. Eradication - absence of the baseline pathogen from lower respiratory tract culture and blood (if obtained). Presumed eradication - no source to culture and participant assessed as clinical response (EOT) or clinical cure (TOC). Persistence - continued presence of the baseline pathogen in lower respiratory tract or blood culture (if obtained). Presumed persistence - no source to culture in a participant judged clinical non-response (EOT) or failure (TOC). Persistence/presumed persistence at EOT are carried forward to TOC. Indeterminate - data missing for any reason and cannot otherwise be deemed unfavorable. Overall response at TOC: Favorable - eradication or presumed eradication of all baseline pathogens; Unfavorable - persistence or presumed persistence of at least one pathogen (EOT unfavorable responses carried forward); Indeterminate - microbiological response data missing for any reason.

    Time frame: EOT (Days 7 to 14) and TOC (Day 21± 2 days)

Other outcomes

  1. Exploratory Endpoints:

    Health economics: * Total number of days in hospital * Number of days in intensive care unit * Number of days on a ventilator

    Time frame: Throughout the study (Day 1 to 35 ± 5 days)

  2. Safety Endpoints (in the Safety Analyses set):

    The number and percent of trial participants with TEAEs and the number and percent of trial participants with potentially clinically significant changes in clinical safety laboratories and electrocardiograms (ECGs)

    Time frame: Throughout the Study (Day 1 to Day 35 ± 5 days)

07

Study locations

55 sites
  • University Clinical Centre of the Republic of Srpska, Clinic for Anaesthesiology and Intensive Care, Banja Luka
    Banja Luka, Bosnia and Herzegovina 78 000, Bosnia and Herzegovina
  • University Clinical Centre of the Republic of Srpska; Medical Intensive Care Unit
    Banja Luka, Bosnia and Herzegovina 78 000, Bosnia and Herzegovina
  • University Clinical Hospital Mostar; Department of Pulmonary Diseases
    Mostar, Bosnia and Herzegovina 88000, Bosnia and Herzegovina
  • Clinical Center University of Sarajevo; Clinic For Infectious Disease
    Sarajevo, Sarajevo 71000, Bosnia and Herzegovina
  • Acibadem City Clinic UMHAT Tokuda, Clinic of Anesthesiology and Intensive Care
    Sofia, Sofia City Province 1407, Bulgaria
    • Prof. Nikolay Mladenov · Contact · nikidoc@abv.bg · +359 887 64 01 65
  • UMHAT "Aleksandrovska" EAD
    Sofia, Sofia City Province 1431, Bulgaria
  • Military Medical Academy
    Sofia, Sofia City Province 1606, Bulgaria
  • Clinical Hospital Merkur
    Zagreb, City of Zagreb 10000, Croatia
  • Dubrava University Hospital
    Zagreb, City of Zagreb 10000, Croatia
  • University Hospital Centre Zagreb
    Zagreb, City of Zagreb 10000, Croatia
  • Roger Salengro Hospital, Lille University Hospital (CHRU)
    Lille, Nord 59037, France
  • Pitié-Salpêtrière Hospital (AP-HP, Sorbonne University)
    Paris, Paris 75651, France
  • APHP Bichat hospital
    Paris, Paris 75877, France
  • Victor Dupouy Hospital
    Argenteuil, Val-d'Oise 95107, France
  • Israeli - Georgian Medical Research Clinic Healthycore - Tbilisi
    Tbilisi, K'alak'i T'bilisi 0112, Georgia
  • LTD "New Hospital"
    Tbilisi, K'alak'i T'bilisi 0114, Georgia
  • "Geo Hospitals Tbilisi Multiprofile Medical Centre" LTD
    Tbilisi, K'alak'i T'bilisi 0144, Georgia
  • Multiprofile Clinic Consilium Medulla
    Tbilisi, K'alak'i T'bilisi 0186, Georgia
  • University General Hospital Attikon General Hospital Of West Attica H Agia Varvara, 4th Department of Internal Medicine
    Chaïdári, Attica 124 61, Greece
  • University General Hospital of Heraklion, Department of Intensive Care Medicine
    Heraklion, Crete 715 00, Greece
  • Hippokration Hospital of Thessaloniki
    Thessaloniki, Thessaloniki Regional Unit 54642, Greece
  • General Hospital of Thessaloniki "George Papanikolau
    Eksochi, Thessaloniki 57010, Greece
  • Fortis Memorial Research Institute (FMRI)
    Gurgaon, Haryana 122002, India
  • P. D. Hinduja Hospital & MRC
    Mumbai, Maharashtra 400016, India
  • Lilavati Hospital
    Mumbai, Maharashtra 400050, India
  • Bharati Hospital & Research Centre,
    Pune, Maharashtra 411043, India
  • Max Super Speciality Hospital
    New Delhi, National Capital Territory of Delhi 110017, India
  • Accord Hospital
    Pimpri-Chinchwad, Pune 412105, India
  • SMS Medical College and Hospital
    Jaipur, Rajasthan 302004, India
  • SRM Medical College Hospital and Research Centre
    Chengalpattu, Tamil Nadu 603203, India
  • Yashoda Hospital
    Secunderabad, Telangana 500003, India
  • Medanta Super Speciality Hospital
    Lucknow, Uttar Pradesh 226030, India
  • Humanitas Research Hospital - Rozzano
    Rozzano, Lombardy 20089, Italy
  • Vilnius University hospital Santaros klinikos
    Vilnius, Vilnius City Municipality 08661, Lithuania
  • PMSI Institute of Emergency Medicine
    Chisinau, Chișinău Municipality 2004, Moldova
  • Republican Clinical Hospital
    Chisinau, Chișinău Municipality 2025, Moldova
  • Gheorghe Paladi Chisinau Municipal Clinical Hospital
    Chisinau, Chișinău Municipality 2038, Moldova
  • PHI City General Hospital "8-mi Septemvri" Skopje
    Skopje, Greater Skopje 1000, North Macedonia
  • PHI University Clinic for Infectious Diseases and Febrile Conditions
    Skopje, Greater Skopje 1000, North Macedonia
  • PHI University Clinic for Pulmonology and Allergology;
    Skopje, Greater Skopje 1000, North Macedonia
  • PHI University Clinic for Traumatology,Orthopedics,Anesthesia,Reanimation,Intensive Care - Skopje
    Skopje, Greater Skopje 1000, North Macedonia
  • PHI University Clinic of Cardiology - Skopje
    Skopje, Greater Skopje 1000, North Macedonia
  • University Clinic for Surgical Disease "St.Naum Ohridski - Skopje"
    Skopje, Greater Skopje 1000, North Macedonia
  • University Clinical Hospital No.4, Lublin, Anesthesiology Intensive Therapy
    Lublin, Lublin Voivodeship 20-090, Poland
  • University Clinical Hospital in Opole
    Opole, Opole Voivodeship 45-401, Poland
  • 5th Military Clinical Hospital with Polyclinic, Independent Public Health Care Institution (SPZOZ)
    Krakow, Poland 30-901, Poland
  • Independent Public Clinical Hospital No. 1 in Zabrze
    Zabrze, Silesian 41-800, Poland
  • Spitalul Universitar de Urgenta Elias
    Bucharest, Bucharest 011461, Romania
  • Spitalul Clinic De Urgenta "Sf. Pantelimon" Bucuresti
    Bucharest, Bucharest 021659, Romania
  • Spitalul Clinic Judetean Mures
    Târgu Mureş, Mureș County 540103, Romania
  • Spitalul Clinic Judetean De Urgenta "Pius Brinzeu" Timisoara
    Timișoara, Timiș County 300723, Romania
  • University Clinical Center of Serbia, Center for Anesthesiology and Resuscitation - Department of anesthesiology, resuscitation and intensive care at the Emergency Centre
    Belgrade, Belgrade 11000, Serbia
  • Vascular Diseases, Department of Intensive Care and Intoxication
    Belgrade, Belgrade 11000, Serbia
  • University Clinical Center Nis, Pulmonology Clinic
    Niš, Nisava 18000, Serbia
  • Institute of Pulmonary Diseases of Vojvodina, Clinic for Intensive Medicine and Pulmonary
    Kamenitz, Vojvodina 21204, Serbia
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 21, 2026
First posted
Oct 21, 2026
StartEst.
Oct 28, 2026
Primary completionEst.
Dec 31, 2027
CompletionEst.
Dec 31, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07885891
Lead sponsor
Wockhardt
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Oct 28, 2026 (estimated)
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Ranjeet Gutte Vice President, Global Clinical Development
Contact
rgutte@wockhardt.com
9819858489

Oversight

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

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