Colistin Monotherapy vs Colsitin-fosfomycine in CRAB Infection
NCT ID: NCT06570850
Last Updated: 2024-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
188 participants
INTERVENTIONAL
2023-04-01
2025-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Colistin group
Participants receive intravenous colistin (colistinmethate soidum) 5 mg/kg/day (dosage will be adjusted according to creatinine clearance) and colistin nebulization at 80 mg every 8 hours in case of pneumonia.
Colistin Sodium Methanesulfonate
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.
Colistin plus fosfomycin group
Participants receive intravenous colistin (colistinmethate soidum) (dosage regimen same as colistin group plus intravenous fosfomycin (dosage will be adjusted according to creatinine clearance and MIC).
Colistin Sodium Methanesulfonate plus Fosfomycin
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.
Interventions
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Colistin Sodium Methanesulfonate
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.
Colistin Sodium Methanesulfonate plus Fosfomycin
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Complicated infection with inadequate source controlled
* Intracranial infection
* Infective endocarditis
* Intraabdominal infection
* Bone and joint infection
* Allergic to or have contraindication(s) to any treatment regimen in the study
* Polymicrobial infection with Carbapenem-resistant Psuedomonas aeruginosa, Carbapenem-resistant Enterobacterales (CRE), Vancomycin-resistant Enterococcus (VRE)
* Pregnancy
* Previous treatment with colistin or fosfomycin more than 96 hours
* Life expectancy of 24 hour or less
* Refusal to participate in the study
* Hospice treatment
20 Years
ALL
No
Sponsors
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Chiang Mai University
OTHER
Responsible Party
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Parichat Salee
Assistant professor Parichat sales
Principal Investigators
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Athitaya Luangnara
Role: PRINCIPAL_INVESTIGATOR
Chiang Mai University
Locations
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Faculty of medicine, Chiang Mai university
Chiang Mai, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MED-2566-09378
Identifier Type: -
Identifier Source: org_study_id
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