Comparison of the safety and efficacy of empirical use of colistin monotherapy versus colistin plus minocycline combination therapy in ventilator associated pneumonia(VAP) due to carbapenem resistant gram negative organism infection - a randomized controlled trial

Comparison of the safety and efficacy of empirical use of colistin monotherapy versus colistin plus minocycline combination therapy in ventilator associated pneumonia(VAP) due to carbapenem resistant gram negative organism infection - a randomized controlled trial - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059832

Enrollment

200

Registered

2023-11-14

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

Intervention1: Colistin plus minocycline combination therapy: Intravenous colistin a loading dose of 9 million international units (MIU) of colistin followed by a maintenance dose of 4.5 MIU every 12

Control Intervention1: Colistin monotherapy: Intravenous colistin a loading dose of 9 million international units (MIU) of colistin followed by a maintenance dose of 4.5 MIU every 12 h Plus Colistin N

Eligibility

Inclusion criteria

Inclusion criteria: 1. Hospitalized and receiving mechanical ventilation for at least 48 hours at the time of study enrolment 2. Patient with VAP diagnosis as per hospital protocol definition# 3. Endotracheal aspirate sample sent for culture and sensitivity prior to study drug initiation. 4. Legally acceptable representative(LAR) providing informed consent, and willing to give follow up

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to any of the two antimicrobials of the study (colistin/ minocycline). 2. Received colistin/polymyxins therapy or minocycline for a minimum time period of 72 hours within 96 hours prior to randomization 3. Renal insufficiency. [eGFR 4. Patients included in another clinical trial in the past three months. 5. Pregnant or nursing woman 6. Patients with neutropenia (WBC 7. Presence of primary infection at other sites, e.g., osteomyelitis, endocarditis, prosthetic joint infection, meningitis, or central nervous system infection

Design outcomes

Primary

Measure	Time frame
To compare the mortality rate in both the study groupsTimepoint: Day 0, day 3, Day 7, Day 10, Day 14, and Day 28	—

Secondary

Measure	Time frame
To compare two study groups for- A] Adverse events B] Proportion of patients with clinical failure C] Duration of hospitalization D] Duration of Intensive Care Unit(ICU) stay, E] Days on ventilator F] Microbiological clearance of culture-proven organisms g] Organism specific treatment response Timepoint: Day 0, day 3, Day 7, Day 10, Day 14, and Day 28	—

Countries

India

Contacts

Public ContactAmol

PGIMER Chandigarh

smal.pgi@gmail.com9417016343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026