Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection

January 13, 2023 updated by: Mahidol University

Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Therapy of Carbapenem-Resistant Acinetobacter Baumannii Infection

Acinetobacter baumannii causes severe infections (pneumonia, bacteremia, organ space) with high lethality in hospitalised critically ill patients. It can acquire resistance to all classes of antibiotics (multidrug resistance, MDR) except an 'old' drug, colistin, which may be the only therapeutic option. The addition of minocycline to colistin has been shown to be synergistic in vitro, and may be promising in vivo, but this combination has not been limited to case report or case series in comparison with colistin alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this double-blind, randomized, parallel, placebo-controlled clinical trial is to assess whether the association of colistin and minocycline reduces significantly the mortality of patients with severe MDR A. baumannii infections compared with colistin alone.

The trial will enroll 94 patients from internal medicine ward and intensive care units (ICU) of an university care hospitals where MDR A. baumannii infection is endemic with epidemic phases. Patients will be randomly allocated to either colistin plus placebo (control arm) or colistin plus minocycline (experimental arm).

Primary end point is overall mortality, defined as death occurring within 28 days from randomisation.

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Phase 4

Contacts and Locations

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

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:
        • Principal Investigator:
          • Adhiratha Boonyasiri, MD

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

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical and microbiological evidence of a severe infection due to multi-drug resistant A. baumannii during hospitalization
  • Susceptibility of the A. baumannii isolate to colistin (MIC < or =2 mg/l).

Exclusion Criteria:

  • Treatment with one of the study drugs prior to the diagnosis of A. baumannii infection more than 48 hours
  • Severe liver dysfunction
  • History of prior hypersensitivity to the study drugs
  • Pregnancy and lactation

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Colistin plus Minocycline
Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally
Drug: Colistin
150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days
Other Names:
  • Sodium colistimethate
Drug: Minocycline
200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days
Other Names:
  • Mino
Active Comparator: Colistin plus Placebo
Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo
Drug: Colistin
150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days
Other Names:
  • Sodium colistimethate
Drug: Placebo
Capsule without active compound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: 28 days
The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological eradication
Time Frame: 28 days
Microbiological eradication is defined as the disappearance of A. baumannii in cultures from blood, bronchial aspirate, urines and drainage fluids.
28 days
Incidence of Renal toxicity (safety)
Time Frame: 28 days
Renal toxicity is defined as decrease of creatinine clearance below 50 ml/min or >50% reduction in the creatinine clearance relative to the baseline.
28 days
Incidence of Hepatic toxicity (safety)
Time Frame: 28 days
Hepatic toxicity is defined as increase of direct bilirubin above 3 mg/dl.
28 days

Collaborators and Investigators

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

Sponsor

Mahidol University

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.

General Publications

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)

January 10, 2023

Primary Completion (Anticipated)

January 31, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI-CEU-03-2022

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.

Subscribe