NCT05586815

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acinetobacter Infections

Interventions

Type	Name	Description
DRUG	Colistin	150 mg every 8 hours intravenously for at least 7 and up to a maximum of 28 days
DRUG	Minocycline	200 mg every 12 hours orally for at least 7 and up to a maximum of 28 days
DRUG	Placebo	Capsule without active compound

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-01-31
• Completion: 2024-06-30
• First posted: 2022-10-19
• Last updated: 2023-01-18

Locations

1 site across 1 country: Thailand