This is a randomised, open-labelled, controlled trial to compare the efficacy and effectiveness on relapse-free rate of 12-week versus 20-week oral eradication treatment of melioidosis. The study population includes 800 patients with culture-confirmed melioidosis whom 12 weeks of oral eradication therapy have been completed with or without intravenous intensive antibiotics. Patients will be randomised to either stop the eradication treatment or continue current oral treatment for 8 more weeks. The study aim to optimise the regimen used to treat melioidosis for better compliance and reducing unnecessary use of antibiotics.
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
667
Receive treatment with co-trimoxazole for 12 weeks.
Receive treatment with co-trimoxazole for 20 weeks.
Khon Kaen Univerisity
Khon Kaen, Thailand
1-year non relapse rate
This is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkhoderia pseudomallei. This can be any time point during or after stopping antibiotic treatment.
Time frame: 1 year
Clinical Recurrence
Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture.
Time frame: 1 year
Treatment failure
Clinical decision to change treatment according to inadequate response to therapy.
Time frame: 9 weeks
Mortality
Time frame: 1 year
Adverse Drug Reactions
Adverse events that are caused by the drug including drug allergy.
Time frame: 9 weeks
Drug compliance
This will be done by interviewing and pill counting.
Time frame: 12 or 20 weeks
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