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

NCT05586815 | Unknown Phase 4 DMC

• 1 other identifier: SI-CEU-03-2022
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Acinetobacter Infections

Keywords

colistin; minocycline; carbapenem-resistant Acinetobacter baumannii

Outcome Measures

Primary Outcomes (1)

• All cause mortality

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

  28 days

Secondary Outcomes (3)

• Microbiological eradication

  28 days

• Incidence of Renal toxicity (safety)

  28 days

• Incidence of Hepatic toxicity (safety)

  28 days

Study Arms (2)

Colistin plus Placebo

ACTIVE COMPARATOR

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

Drug: Colistin; Drug: Placebo

Colistin plus Minocycline

EXPERIMENTAL

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

Drug: Colistin; Drug: Minocycline

Interventions

Colistin DRUG

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

Also known as: Sodium colistimethate

Colistin plus Minocycline; Colistin plus Placebo

Minocycline DRUG

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

Also known as: Mino

Colistin plus Minocycline

Placebo DRUG

Capsule without active compound

Colistin plus Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

RECRUITING

Related Publications (2)

• 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.

  PMID: 17291803 BACKGROUND

• 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.

  PMID: 26725031 BACKGROUND

MeSH Terms

Conditions

Acinetobacter Infections; cyclopia sequence

Interventions

Colistin; colistinmethanesulfonic acid; Minocycline

Condition Hierarchy (Ancestors)

Moraxellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Polymyxins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Adhiratha Boonyasiri, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adhiratha Boonyasiri, MD

CONTACT

+66850632181; adhiratha.bon@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind, Placebo Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Phase 4 Randomized, Double blind, Placebo Controlled

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 19, 2022
• Study Start: January 10, 2023
• Primary Completion: January 31, 2024
• Study Completion: June 30, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)