NCT01420341

Co-trimoxazole as Maintenance Therapy for Melioidosis

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Melioidosis

Interventions

Type	Name	Description
DRUG	Co-trimoxazole 12	Receive treatment with co-trimoxazole for 12 weeks.
DRUG	Co-trimoxazole 20	Receive treatment with co-trimoxazole for 20 weeks.

Timeline

• Start date: 2011-08-01
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2011-08-19
• Last updated: 2020-09-03

Locations

1 site across 1 country: Thailand