7-days Versus 14 Days of Antibiotics Therapy for Ventilator Associated Pneumonia

NCT03477292 | Completed DMC

• 1 other identifier: IEC/82
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

There is evidence that using shorter antibiotic regimens may help in decreasing antimicrobial resistance and reducing drug-related adverse events.6 Moreover, short-course treatments were found to be as effective as longer-course antibiotic treatment.7,8 In a pooled analysis of four randomized trials in VAP comparing shorter versus long duration of antibiotics in the management of VAP, no difference in the mortality was found. We hypothesize that the use of short course of antibiotics in the treatment of VAP due to drug resistant Acinetobacter baumanii (sensitive to carbapenems and/or colistin only) may result in a higher antibiotic-free days and drug related adverse events, in comparison to a longer duration of antibiotics. In this study, we propose to study a 7-day versus 14-day course of antibiotics in patients with drug-resistant Acinetobacter baumanii.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• Relapses of VAP

  defined as repetitive clinically and microbiologically documented VAP due to the same pathogen

  28 days

Secondary Outcomes (4)

• Duration of mechanical ventilation

  28 days

• ICU and hospital length of stay

  90 days

• 28-day mortality

  28 days

• Antibiotic free days

  28 days

Study Arms (2)

Long duration of antibiotics

EXPERIMENTAL

14 days of Colistin

Drug: Duration of antibiotic

Short duration of antibiotics

ACTIVE COMPARATOR

7 days of Colistin

Drug: Duration of antibiotic

Interventions

Duration of antibiotic DRUG

Duration of antibiotic for treatment of VAP

Also known as: Colisitin

Long duration of antibiotics; Short duration of antibiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) Patients who develop ventilator associated pneumonia due to drug-resistant Acinetobacter baumanii; (b) age group of 18 to 75 years

You may not qualify if:

• (a) VAP due to other organisms; (b) pregnancy; (c) endotracheal or tracheostomy tube aspirate demonstrating growth of drug sensitive Acinetobacter baumanii or an organism other than Acinetobacter baumanii; and, (c) failure to provide informed consent.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (2)

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Respiratory ICU, Post Graduate Institue of Medical Education and Research

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized trial

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: March 26, 2018
• Study Start: March 1, 2018
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

IN (2)