Colistin Versus Colistin Combined With Cefoperazone-sulbactam for Multiresistant Acinetobactor Baumannii Ventilator-associated Pneumonia Treatment (CRAB)

June 22, 2026 updated by: Renuka Kahuja, Shaheed Mohtarma Benazir Bhutto Institue of Trauma
This study aims to evaluate clinical outcomes of colistin versus colistin in combination with cefoperazone-sulbactam for patients with MDR-AB VAP treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

MDR-AB (multidrug-resistant Acinetobacter baumannii) has been an increasingly common cause of ventilator-associated pneumonia (VAP) in intensive care unit (ICU). Colistin remains the last available antibiotic choice. Unfortunately, colistin monotherapy is often inadequate for microbiologic eradication and a risk factor of nephrotoxicity and for heteroresistance.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Karachi, Pakistan
        • Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis of VAP due to A. baumannii

Exclusion Criteria:

  • patients who had polymicrobial VAP
  • Patients with pre-existing severe renal failure and/or abnormal liver function tests
  • Patients allergic to colistin or cefoperazone-sulbactam

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention group received colistin plus cefoperazone-sulbactam combination group.
Drug: colistin plus cefoperazone-sulbactam combination group
Combination therapy
Active Comparator: Comparator
Comparator group received colistin monotherapy
Drug: Colistin
Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: within one week
Clinical response was defined as observable improvement in the patient's clinical signs/symptoms, including absence of fever (temp<38ºC) for three consecutive days or more, and decreasing amount and purulence of tracheal secretions
within one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological response
Time Frame: within one week
Radiological response was defined as improvement/resolution of pulmonary infiltrates, as noted on chest x-rays following treatment.
within one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

April 30, 2026

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 26, 2026

Study Record Updates

Last Update Posted (Actual)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-000154/SMBBIT/Approval/202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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