Hospital Acquired Bacterial Pneumonia (HABP)Phase 3NCT07885891
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
A Phase 3 study testing Cefepime-Zidebactam and Ceftazidime-avibactam with or without Colistin in people with Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP), run by Wockhardt at 55 sites in 14 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
- What is being tested?
- Cefepime-Zidebactam and Ceftazidime-avibactam with or without Colistin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 55 sitesin 14 countries
- Study dates
- 28 Oct 2026to 31 Dec 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age.
- 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.
- 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
Show all 28Show fewer
- WBC count of <4,500 cells/mm3
- Bandemia (immature neutrophils) on a WBC count of >15%
- Meet ALL the following clinical criteria for either:
- VABP:
- Receiving continuous mechanical ventilation ≥48 hours prior to the onset of signs and symptoms of pneumonia.
- 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.
- 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.
- HABP:
- 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).
- New or worsening infiltrate consistent with pneumonia on X-ray or chest CT obtained at least 48 hours or more after hospital admission.
- 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.
Who cannot join
- 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.
- Current pneumonia due to Stenotrophomonas or Burkholderia species identified on culture prior to randomization.
- Known or suspected community-acquired, viral, fungal (including Pnuemocystis jirovecii), mycobacterial (including tuberculous), or parasitic pneumonia.
- Diagnosed or suspected to have atypical pneumonia (including Legionella pneumophilia) or a positive test result on the BPP for an atypical organism.
- Current pneumonia known or suspected to be caused by an organism that is resistant to FEP-ZID or to both CAZ-AVI and colistin.
- Diagnosed with COVID-19 or positive test for SARS-CoV-2 virus within the past 2 weeks.
Show all 37Show fewer
- 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
- 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.
- 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.
- Receipt of CAZ-AVI or FEP-ZID within 30 days prior to enrolment for treatment of any infection.
- 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
- Pneumonia caused by sole gram-positive pathogen(s) if known based on culture report or BPP result.
- 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.
- APACHE II score of >30.
- History of epilepsy or seizure disorder requiring current treatment with anti-seizure medication.
- Women who are pregnant or nursing.
- 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.
- 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
- 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.
- On extracorporeal membrane oxygenation (ECMO) or expected to receive ECMO within 72 hours.
- Current neutropenia defined as <500 neutrophils/ mm3, or platelet count <50,000 per mL.
- Have received solid organ, stem cell, bone marrow transplant or had splenectomy.
- History of Clostridioides difficile-associated disease within 6 months prior to enrolment.
- 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.
- 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.
- 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.
Trial locations and contacts
55 sites in 14 countries. Contact the study team or a site near you to ask about taking part.
55 sites in 14 countries
India10 sites
SRM Medical College Hospital and Research Centre
Chengalpattu, Tamil Nadu, 603203
Dr Swarnalingam Thangavelu, 8144008182, swarnalt@srmist.edu.in
Fortis Memorial Research Institute (FMRI)
Gurgaon, Haryana, 122002
Dr Neha Rastogi, 9582777566, neha.rastogi@fortishealthcare.com
SMS Medical College and Hospital
Jaipur, Rajasthan, 302004
Dr. Sunil Kumar Mahavar, 9460259469, dr.sunilmahavar09@gmail.com
Medanta Super Speciality Hospital
Lucknow, Uttar Pradesh, 226030
Dr Dilip Kumar Dubey, 9369047990, Dilip.Dubey@Medanta.org
P. D. Hinduja Hospital & MRC
Mumbai, Maharashtra, 400016
Dr. Umang Agarwal, 9920585075, dr_umang.agrawal@hindujahospioital.com
Lilavati Hospital
Mumbai, Maharashtra, 400050
Dr Prabhudesai Pralhad Prabhakar, 9821053689, drprabhudesai09@gmail.com
Max Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110017
Dr Deven Juneja, 98180290380, Deven.juneja@maxhealthcare.com
Accord Hospital
Pimpri-Chinchwad, Pune, 412105
Dr Ramshyam Agarwal, 8087282022, ramshyamagarwal20@gmail.com
Bharati Hospital & Research Centre,
Pune, Maharashtra, 411043
Dr Jignesh Navinchandra Shah, 9028246946, jignesh.shah@bharatividyapeeth.edu
Yashoda Hospital
Secunderabad, Telangana, 500003
Dr Madhusudan Rameshlal Jaju, 9440379476, madhu_jaju123@rediffmail.com
North Macedonia6 sites
PHI City General Hospital "8-mi Septemvri" Skopje
Skopje, Greater Skopje, 1000
Dr. Daniela Buklioska Ilievska, +389 70 304 066, dbuklioska@yahoo.com
PHI University Clinic for Infectious Diseases and Febrile Conditions
Skopje, Greater Skopje, 1000
Dr. Katerina Spasovska, +38971223277, kspasovska@infektivnaklinika.mk
PHI University Clinic for Pulmonology and Allergology;
Skopje, Greater Skopje, 1000
Dr.Deska Dimitrievska, +38923147174, deskadimitrievska@gmail.com
PHI University Clinic for Traumatology,Orthopedics,Anesthesia,Reanimation,Intensive Care - Skopje
Skopje, Greater Skopje, 1000
Dr. Marta Treneva Nicevska, +38978206316, martatrenevanicevska@yahoo.com
PHI University Clinic of Cardiology - Skopje
Skopje, Greater Skopje, 1000
Sasko Kedev, +38970225662, skedev@gmail.com
University Clinic for Surgical Disease "St.Naum Ohridski - Skopje"
Skopje, Greater Skopje, 1000
Dr. Abbas Nebilj, +38970792112, abbas.nebil@yahoo.com
Bosnia and Herzegovina4 sites
University Clinical Centre of the Republic of Srpska, Clinic for Anaesthesiology and Intensive Care, Banja Luka
Banja Luka, Bosnia and Herzegovina, 78 000
Dr Dragan Rakanović, +387 65 984 381, dragan.rakanovic1@gmail.com
University Clinical Centre of the Republic of Srpska; Medical Intensive Care Unit
Banja Luka, Bosnia and Herzegovina, 78 000
Prof. dr Pedja Kovacevic, +38765668400, peko051@yahoo.com
University Clinical Hospital Mostar; Department of Pulmonary Diseases
Mostar, Bosnia and Herzegovina, 88000
Prof. dr. Kristina Galic, +38763893131, kgkristinagalic@gmail.com
Clinical Center University of Sarajevo; Clinic For Infectious Disease
Sarajevo, Sarajevo, 71000
Prof.dr. Rusmir Baljic, +387 61 835 166, rusmir.ba@gmail.com
France4 sites
Victor Dupouy Hospital
Argenteuil, Val-d'Oise, 95107
Dr.Gaetan Plantefeve, +33 1-34-23-27-91, gaetan.plantefeve@ch-argenteuil.fr
Roger Salengro Hospital, Lille University Hospital (CHRU)
Lille, Nord, 59037
Dr. Guillaume Millot, +33 3 62 94 36 48, guillaume.millot@chu-lille.fr
Pitié-Salpêtrière Hospital (AP-HP, Sorbonne University)
Paris, Paris, 75651
Prof. Charles-Edouard Luyt, +33 1 42 16 38 24, charles-edouard.luyt@aphp.fr
APHP Bichat hospital
Paris, Paris, 75877
Dr. Jean-Francois Timsit, +33 1-57-27-75-21, jean-francois.timsit@bch.aphp.fr
Georgia4 sites
Israeli - Georgian Medical Research Clinic Healthycore - Tbilisi
Tbilisi, K'alak'i T'bilisi, 0112
Levan Sukhishvili, +995 599 328 85, Sukhishvililevan@gmail.com
LTD "New Hospital"
Tbilisi, K'alak'i T'bilisi, 0114
Dr. Sophio Chkhikvadze, +995577430822, s.chkhikvadze@newhospitals.ge
"Geo Hospitals Tbilisi Multiprofile Medical Centre" LTD
Tbilisi, K'alak'i T'bilisi, 0144
Mamuka Kapanadze, +995 577 091 101, mamukakapanadze@gmail.com
Multiprofile Clinic Consilium Medulla
Tbilisi, K'alak'i T'bilisi, 0186
Dr. Sandro Megrelishvili, +995 555 961 485, sandromegrelishvili@yahoo.com
Greece4 sites
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara, 4th Department of Internal Medicine
Chaïdári, Attica, 124 61
Prof. Giamarellos-Bourboulis, Evangelos J, +306945521800, giamarel@ath.forthnet.gr
General Hospital of Thessaloniki "George Papanikolau
Eksochi, Thessaloniki, 57010
Dr Christina Iasonidou, +30 2313307653, ciasonidou@gmail.com
University General Hospital of Heraklion, Department of Intensive Care Medicine
Heraklion, Crete, 715 00
Prof .Eumorfia Kondili, +30 2810392636, kondylie@uoc.gr
Hippokration Hospital of Thessaloniki
Thessaloniki, Thessaloniki Regional Unit, 54642
Assist.Prof. Elias Iosifidis, +3069472744434, iosifidish@gmail.com
Poland4 sites
5th Military Clinical Hospital with Polyclinic, Independent Public Health Care Institution (SPZOZ)
Krakow, Poland, 30-901
Prof.Wojciech Szczeklik, +48 126308263, wszczeklik@gmail.com
University Clinical Hospital No.4, Lublin, Anesthesiology Intensive Therapy
Lublin, Lublin Voivodeship, 20-090
Wojciech Dąbrowski, +48817244332, wojciech.dabrowski@umlub.edu.pl
University Clinical Hospital in Opole
Opole, Opole Voivodeship, 45-401
Dr hab.n.med. Tomasz Czarnik, +48 774520302, tomasz.czarnik@usk.opole.pl
Independent Public Clinical Hospital No. 1 in Zabrze
Zabrze, Silesian, 41-800
Dr. Szymon Białka, +48 606 493 210, szymon.bialka@gmail.com
Romania4 sites
Spitalul Universitar de Urgenta Elias
Bucharest, Bucharest, 011461
Dr Silvius Ioan Negoita, +40 722415575, silviusneg@gmail.com
Spitalul Clinic De Urgenta "Sf. Pantelimon" Bucuresti
Bucharest, Bucharest, 021659
Andreea Isabela Tiglea, +40 721 203 082, isatam@yahoo.com
Spitalul Clinic Judetean Mures
Târgu Mureş, Mureș County, 540103
Dr. Mircea Stoian, +40 745200362, mircea.stoian@umfst.ro
Spitalul Clinic Judetean De Urgenta "Pius Brinzeu" Timisoara
Timișoara, Timiș County, 300723
Dr Ovidiu-Horea Bedreag, +40 722371641, bedreag.ovidiu@umft.ro
Serbia4 sites
University Clinical Center of Serbia, Center for Anesthesiology and Resuscitation - Department of anesthesiology, resuscitation and intensive care at the Emergency Centre
Belgrade, Belgrade, 11000
Prof. dr Bojan Jovanovic, +381641275355, bjovanovic@outlook.com
Vascular Diseases, Department of Intensive Care and Intoxication
Belgrade, Belgrade, 11000
Prof. dr Ivan Palibrk, +38162227763, ivanpalibrk@yahoo.com
Institute of Pulmonary Diseases of Vojvodina, Clinic for Intensive Medicine and Pulmonary
Kamenitz, Vojvodina, 21204
Dr. Srdjan Gavrilovic, +381646154744, srdjan_gavrilovic@yahoo.com
University Clinical Center Nis, Pulmonology Clinic
Niš, Nisava, 18000
Dr. Ivana Stankovic, +381 63 109 5100, staivana@gmail.com
Bulgaria3 sites
Acibadem City Clinic UMHAT Tokuda, Clinic of Anesthesiology and Intensive Care
Sofia, Sofia City Province, 1407
Prof. Nikolay Mladenov, +359 887 64 01 65, nikidoc@abv.bg
UMHAT "Aleksandrovska" EAD
Sofia, Sofia City Province, 1431
Assoc. Prof. Dr Yordanka Yamakova, +359879686238, yamakovayordanka@gmail.com
Military Medical Academy
Sofia, Sofia City Province, 1606
Prof. Konstantin Ramshev, +359 887 202 128, kramshev@yahoo.com
Croatia3 sites
Clinical Hospital Merkur
Zagreb, City of Zagreb, 10000
Assoc.Prof.Jadranka Pavičić Šarić, +385 1 2253 358, jpsaric@kb-merkur.hr
Dubrava University Hospital
Zagreb, City of Zagreb, 10000
Assoc.Prof. Andrej Šribar, +385959404034, asribar@sfzg.hr
University Hospital Centre Zagreb
Zagreb, City of Zagreb, 10000
Robert Baronica, PhD, MD, +385915358627, rbaronica@gmail.com
Moldova3 sites
PMSI Institute of Emergency Medicine
Chisinau, Chișinău Municipality, 2004
Dr. Sergiu Cobiletchi, +373 69103157, s.cobiletchi@gmail.com
Republican Clinical Hospital
Chisinau, Chișinău Municipality, 2025
Prof. Victor Cojocaru, +37369118707, cojocaruv@mail.ru
Gheorghe Paladi Chisinau Municipal Clinical Hospital
Chisinau, Chișinău Municipality, 2038
Ion Chesov, +373 69565570, ion.chesov@usmf.md
Italy1 site
Humanitas Research Hospital - Rozzano
Rozzano, Lombardy, 20089
Michelle Bartoletti, +393496473299, michele.bartoletti@hunimed.eu
Lithuania1 site
Vilnius University hospital Santaros klinikos
Vilnius, Vilnius City Municipality, 08661
Dr Ingrida Lisauskiene, +37061216477, ingrida.lisauskiene@santa.lt
About this study
Official title: A Phase 3, Randomized, Double-Blind, Multicenter, Comparative Study of Cefepime-Zidebactam Compared With Ceftazidime-avibactam With or Without Colistin in the Treatment of Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.
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.
- Conditions
- Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
- Being tested
- Cefepime-Zidebactam, Ceftazidime-avibactam with or without Colistin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefepime-ZidebactamDrug
3 g (2 g FEP + 1 g ZID) IV every 8 hours (q8h), infused over 60 ± 5 minutes for 7 to 14 days
Ceftazidime-avibactam with or without ColistinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cefepime-Zidebactam | Experimental | Not described Receives: Drug: Cefepime-Zidebactam |
| Ceftazidime-avibactam with or without Colistin | Active comparator | Not described Receives: Drug: Ceftazidime-avibactam with or without Colistin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (7)
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.
Measured: Day 28
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.
Measured: EOT (Days 7 to 14)
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.
Measured: TOC (Day 21± 2 days)
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.
Measured: Day 35 ± 5 days
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.
Measured: Day 35 ± 5 days
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.
Measured: Day 35 ± 5 days
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.
Measured: EOT (Days 7 to 14) and TOC (Day 21± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start28 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital Acquired Bacterial Pneumonia (HABP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wockhardt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885891
- Sponsor's protocol ID
- W-5222-302
- Status last verified
- Oct 2026
- First submitted
- 21 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No