Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorChiang Mai University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 20 years old patients who have CRAB infections (pneumonia, urinary tract infection, skin and soft tissue infection, bloodstream infection)
Able to provide informed consent or having a legal proxy who can provide informed consent in case the subject is unable to provide consent on his own
Disqualifiers
Minimum inhibitory concentration (MIC) of colistin > 2 mg/L
Complicated infection with inadequate source controlled
Intracranial infection
Infective endocarditis
Trial design
Design model
Parallel
Treatments tested in this trial
Colistin Sodium Methanesulfonate
DrugIntravenous 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.
Colistin Sodium Methanesulfonate plus Fosfomycin
DrugIntravenous 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.
Treatment groups
188 Participants
are divided into 2 treatment groupsGroup A: Colistin groupActive comparator 1 intervention
Group B: Colistin plus fosfomycin groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number 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)Secondary outcomes
1
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 32
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 33
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 3Sponsors and contacts
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Source ClinicalTrials.gov