Co-trimoxazole as Maintenance Therapy for Melioidosis

• Status: Completed
• Trial end date: 2019-06-21
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Khon Kaen University
• Treatments: Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

Inclusion Criteria:

1. Age > 15 years

2. Culture-confirmed melioidosis

3. Currently on oral co-trimoxazole for 12(+2) weeks without any clinical evidence of active melioidosis

4. High likelihood of completing at least 6 months follow up

5. Willingness to participate in the study and written, informed consent obtained from the patient

Exclusion Criteria:

1. Pregnancy or breast feeding

2. Contraindications to TMP-SMX: G6PD, severe adverse reactions grade 3-4 occurring during first 12 weeks of treatment

3. Relapse melioidosis with at least 2 year symptom free period from last episode