Co-trimoxazole as Maintenance Therapy for Melioidosis

Khon Kaen University

Status and phase: Completed; Phase 4

Conditions: Melioidosis

Treatments: Drug: Co-trimoxazole 12; Drug: Co-trimoxazole 20

Study type: Interventional

Funder types: Other

Identifiers

NCT01420341

project number 542040 (Other Grant/Funding Number)

106698/B/14/Z (Other Grant/Funding Number)

HE541074

Details and patient eligibility

About

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.

Full description

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

Enrollment: 667 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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667 participants in 2 patient groups

Co-trimoxazole 12

Active Comparator group

Description:

Receive treatment with co-trimoxazole for 12 weeks.

Treatment:

Drug: Co-trimoxazole 12

Co-trimoxazole 20

Experimental group

Description:

Receive treatment with co-trimoxazole for 20 weeks.

Treatment:

Drug: Co-trimoxazole 20