NCT07671755

Brief Summary

This study aims to evaluate clinical outcomes of colistin versus colistin in combination with cefoperazone-sulbactam for patients with MDR-AB VAP treatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2026

Completed
Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

11 months

First QC Date

June 22, 2026

Last Update Submit

June 22, 2026

Conditions

Keywords

multidrug-resistant Acinetobacter baumanniiventilator-associated pneumoniaintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Clinical response

    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 Outcomes (1)

  • Radiological response

    within one week

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention group received colistin plus cefoperazone-sulbactam combination group.

Drug: colistin plus cefoperazone-sulbactam combination group

Comparator

ACTIVE COMPARATOR

Comparator group received colistin monotherapy

Drug: Colistin

Interventions

Monotherapy

Comparator

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Mohtarma Benazir Bhutto Institue of Trauma

Karachi, Pakistan

Location

Related Links

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Colistin

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 22, 2026

First Posted

June 26, 2026

Study Start

February 1, 2025

Primary Completion

December 30, 2025

Study Completion

April 30, 2026

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations