Trial · NCT07885891

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

NCT07885891, Phase 3, Not yet recruiting, Wockhardt

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia. Trials, record NCT07885891. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07885891

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
NCT number: NCT07885891
Status: Not yet recruiting
Phases: Phase 3
Enrollment: 324 participants, estimated
Lead sponsor: Wockhardt
Conditions: Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Interventions: Cefepime-Zidebactam, Ceftazidime-avibactam with or without Colistin
First posted: 2026-10-21
Last updated: 2026-10-21

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	All-cause mortality at 14 days	Day 14	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.
Secondary	All-cause mortality at 28 days	Day 28	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.
Secondary	Clinical Outcome at EOT in the MITT analyses set	EOT (Days 7 to 14)	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.
Secondary	Clinical Outcome at TOC in the MITT analyses set	TOC (Day 21± 2 days)	* 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.
Secondary	Number of Participants with Sustained clinical cure at LFU in the MITT Population	Day 35 ± 5 days	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.
Secondary	Number of Participants with Sustained Clinical Cure at LFU in the mMITT Population	Day 35 ± 5 days	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.
Secondary	Number of Participants with Sustained Clinical Cure at LFU in the CE Population	Day 35 ± 5 days	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.
Secondary	Microbiological Response in the mMITT analyses set	EOT (Days 7 to 14) and TOC (Day 21± 2 days)	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.
Other	Exploratory Endpoints:	Throughout the study (Day 1 to 35 ± 5 days)	Health economics: * Total number of days in hospital * Number of days in intensive care unit * Number of days on a ventilator
Other	Safety Endpoints (in the Safety Analyses set):	Throughout the Study (Day 1 to Day 35 ± 5 days)	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)

Source ClinicalTrials.gov

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT07885891/registered

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