Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-24 @ 4:59 PM
Study NCT ID:
NCT06570850
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-08-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
Sponsor:
Chiang Mai University
Organization:
Study Overview
Official Title:
Efficacy of Colistin Monotherapy Versus Colistin Combined With Fosfomycin Against Carbapenem-Resistant Acinetobacter Baumannii Infections
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to evaluate the efficacy of colistin compared with colistin plus fosfomycin against carbapenem-resistant Acinetobacter baumanii infection in Thailand. The main questions it aims to answer the following main questions:
1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
1. Which group has better clinical response at end of treatment
2. Which group has better clinical response at 72 hours and micrological cure at 72 hours and at end of treatment
Detailed Description:
Participants will be randomized in a 1:1 ratio to receive a combination of intravenous colistin plus intravenous fosfomycin (combination group) or colistin alone (monotherapy group) to determine if monotherapy or combination therapy has a better outcome.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: