Co-trimoxazole as Maintenance Therapy for Melioidosis

Phase 4

Completed

• Conditions: Melioidosis
• Interventions: Drug: Co-trimoxazole 12; Drug: Co-trimoxazole 20

• Registration Number: NCT01420341
• Lead Sponsor: Khon Kaen University

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 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-08-18
• Study First Posted: 2011-08-19
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 667

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Co-trimoxazole 12	Co-trimoxazole 12	Receive treatment with co-trimoxazole for 12 weeks.
Co-trimoxazole 20	Co-trimoxazole 20	Receive treatment with co-trimoxazole for 20 weeks.

Primary Outcome Measures

Name	Time	Method
1-year non relapse rate	1 year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Khon Kaen Univerisity; 🇹🇭 Khon Kaen, Thailand