Co-trimoxazole as Maintenance Therapy for Melioidosis

Study Overview
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Brief Summary
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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.

Detailed Description
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Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.

Official Title
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A Comparison Between 12 vs. 20 Weeks of Co-trimoxazole as Maintenance Therapy for Melioidosis

Conditions
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Melioidosis

Intervention / Treatment
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* Drug: Co-trimoxazole 12
* Drug: Co-trimoxazole 20


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 15 years Culture-confirmed melioidosis Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis High likelihood of completing at least 6 months follow up Willingness to participate in the study and written, informed consent obtained from the patient Exclusion Criteria: Pregnancy or breast feeding Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment Relapse melioidosis with at least 2 year symptom free period from last episode

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Co-trimoxazole 12<br>Receive treatment with co-trimoxazole for 12 weeks. | Drug: Co-trimoxazole 12<br>* Receive treatment with co-trimoxazole for 12 weeks.<br>|
| Experimental: Co-trimoxazole 20<br>Receive treatment with co-trimoxazole for 20 weeks. | Drug: Co-trimoxazole 20<br>* Receive treatment with co-trimoxazole for 20 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Recurrence | Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture. | 1 year | 
| Treatment failure | Clinical decision to change treatment according to inadequate response to therapy. | 9 weeks | 
| Mortality |  | 1 year | 
| Adverse Drug Reactions | Adverse events that are caused by the drug including drug allergy. | 9 weeks | 
| Drug compliance | This will be done by interviewing and pill counting. | 12 or 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melioidosis, Co-trimoxazole, Relapse