Status:
COMPLETED
Co-trimoxazole as Maintenance Therapy for Melioidosis
Lead Sponsor:
Khon Kaen University
Conditions:
Melioidosis
Eligibility:
All Genders
15+ years
Phase:
PHASE4
Brief Summary
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 popu...
Detailed Description
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2019
Estimated Enrollment :
667 Patients enrolled
Trial Details
Trial ID
NCT01420341
Start Date
August 1 2011
End Date
June 21 2019
Last Update
September 3 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Khon Kaen Univerisity
Khon Kaen, Thailand