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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acinetobacter Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Phase 4 Randomized, Double blind, Placebo Controlled

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double blind, Placebo Controlled

Study Groups

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Colistin plus Placebo

Colistin alone, 150 mg every 8 hours intravenously or according to renal function, plus Placebo

Group Type ACTIVE_COMPARATOR

Colistin

Intervention Type DRUG

150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days

Placebo

Intervention Type DRUG

Capsule without active compound

Colistin plus Minocycline

Colistin, 150 mg every 8 hours intravenously or according to renal function, plus Minocycline, 200 mg every 12 hours orally

Group Type EXPERIMENTAL

Colistin

Intervention Type DRUG

150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days

Minocycline

Intervention Type DRUG

200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days

Interventions

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Colistin

150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days

Intervention Type DRUG

Minocycline

200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days

Intervention Type DRUG

Placebo

Capsule without active compound

Intervention Type DRUG

Other Intervention Names

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Sodium colistimethate Mino

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No