Clinical trial NCT05586815: Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Carbapenem-Resistant A. Baumannii Infection
Official title: Efficacy of Colistin Monotherapy Versus Colistin Plus Minocycline for Therapy of Carbapenem-Resistant Acinetobacter Baumannii Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acinetobacter Infections
Keywords: colistin
minocycline
carbapenem-resistant Acinetobacter baumannii
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Phase 4 Randomized, Double blind, Placebo Controlled
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: Microbiological eradication
timeFrame: 28 days
measure: Incidence of Renal toxicity (safety)
timeFrame: 28 days
measure: Incidence of Hepatic toxicity (safety)
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Adhiratha Boonyasiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koomanachai P, Tiengrim S, Kiratisin P, Thamlikitkul V. Efficacy and safety of colistin (colistimethate sodium) for therapy of infections caused by multidrug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in Siriraj Hospital, Bangkok, Thailand. Int J Infect Dis. 2007 Sep;11(5):402-6. doi: 10.1016/j.ijid.2006.09.011. Epub 2007 Feb 8.
citation: Thamlikitkul V, Tiengrim S, Seenama C. Comparative in vitro activity of minocycline and selected antibiotics against carbapenem-resistant Acinetobacter baumannii from Thailand. Int J Antimicrob Agents. 2016 Jan;47(1):101-2. doi: 10.1016/j.ijantimicag.2015.11.006. Epub 2015 Dec 11. No abstract available.