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

Phase 4

Recruiting

• Conditions: Acinetobacter Infections
• Interventions: Drug: Colistin; Drug: Placebo; Drug: Minocycline

• Registration Number: NCT05586815
• Lead Sponsor: Mahidol University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Status Verified: 2023-01
• Study Start: 2023-01-10
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-18
• Primary Completion: 2024-01-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 94

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colistin plus Placebo	Placebo	Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo
Colistin plus Placebo	Colistin	Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo
Colistin plus Minocycline	Colistin	Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally
Colistin plus Minocycline	Minocycline	Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally

Primary Outcome Measures

Name	Time	Method
All cause mortality	28 days	The study primary outcome is patient overall mortality, defined as death occurring during hospitalisation or within 28 days from randomization.

Secondary Outcome Measures

Name	Time	Method
Microbiological eradication	28 days	Microbiological eradication is defined as the disappearance of A. baumannii in cultures from blood, bronchial aspirate, urines and drainage fluids.
Incidence of Renal toxicity (safety)	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.
Incidence of Hepatic toxicity (safety)	28 days	Hepatic toxicity is defined as increase of direct bilirubin above 3 mg/dl.

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand