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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Intravenous colistin (colistinmethate soidum) 5 mg/kg/day intravenous (dosage will be adjusted according to creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.
Intravenous colistin(dosage is same as colistin group) plus intravenous fosfomycin(dosage will be adjusted according to MIC and creatinine clearance). The duration of treatment ranges from 10 to 14 days, depending on the site of infection and clinical responsiveness.
Faculty of medicine, Chiang Mai university
Chiang Mai, Thailand
RECRUITINGNumber of participants with clinical response after completion of therapy
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
Time frame: Baseline, day 10-14 (end of therapy)
Number of participants with clinical response at 72 hours of therapy
Clinical response are categorized as: clinical cure if participants recover all symptoms and signs of infection; partial response if they disappear only some of the initial symptoms and signs of infection, including the condition not fulfilling all the requirements for clinical cure; and clinical failure if participants have persistence or worsening of all symptoms and signs of infection despite antimicrobial treatment.
Time frame: Baseline, day 3
Number of participants with microbiological cure at 72 hours of therapy
Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours
Time frame: Baseline, day 3
Number of participants with microbiological cure after completion of therapy
Microbiological cure: no isolation of the causative agent in the infective site at 72 hours and end of treatment Microbiological failure: persistence of the causative agent in the infective site at 72 hours
Time frame: Baseline, day 3
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