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Clinical Trials/CTRI/2024/02/062539
CTRI/2024/02/062539RecruitingPhase 4

Efficacy of Triple vs Double drug regimens with at least two sensitive antibiotics on the outcome of patients infected with ventilator-associated pneumonia due to carbepenam-resistant Acinetobacter Baumannii: A randomised controlled study.

AIIMS JODHPUR1 site in 1 country174 target enrollmentStarted: February 15, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
174
Locations
1
Primary Endpoint
Comparison of 28-day all-cause mortality between triple and

Study Overview

Brief Summary

The present randomised controlled single-blinded study shall be conducted in adult intensive care at AIIMS JODHPUR after obtaining written informed consent from the patients/patient’s relatives and approval from the institutional ethical committee. The study shall be prospectively registered with a clinical trial registry. Adult patients admitted to the intensive care unit for the duration of our study and meeting our inclusion criterion shall be included in the study. They shall be randomised into two groups using the block randomisation technique where one group will receive dual therapy while the other will receive triple therapy containing at least two sensitive drugs in each. The dual therapy will receive either minocycline 200mg bd with sulbactam high dose if sensitive to minocycline or polymyxin with high dose sulbactam if minocycline resistant. The triple therapy regimen will receive minocycline 200mg bd with polymyxin and sulbactam irrespective of minocycline sensitivity.

The baseline APACHE 2 score and SOFA score at treatment initiation and 48 hours after initiation shall be measured. Crossover from dual to triple therapy will be considered if SOFA rises more than 2 post-treatment initiation or persistence of microbiological positivity at day 4 from treatment initiation.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Having ventilator-associated pneumonia (VAP) infection due to Carbepenam resistant A.
  • Baumannii (CRAB) during ICU stay.

Exclusion Criteria

  • Consent not obtained
  • Pregnant patients
  • Not treated for the infection
  • Infection not likely
  • Allergy to any drug used in the regimen.

Outcomes

Primary Outcomes

Comparison of 28-day all-cause mortality between triple and

Time Frame: Comparison of 28-day all-cause mortality between triple and | dual antibiotic drug regimen for VAP infection due to CRAB.

dual antibiotic drug regimen for VAP infection due to CRAB.

Time Frame: Comparison of 28-day all-cause mortality between triple and | dual antibiotic drug regimen for VAP infection due to CRAB.

Secondary Outcomes

  • Microbiological clearance, length of ventilator stay, length of ICU stay, antibiotic treatment duration, in-hospital mortality, secondary infections post-CRAB infection.(During Hospital stay.)

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Sadik Mohammed

AIIMS, JODHPUR

Study Sites (1)

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