Melioidosis
Conditions
Keywords
Melioidosis, Co-trimoxazole, Relapse
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.
Interventions
DRUGCo-trimoxazole 12
Receive treatment with co-trimoxazole for 12 weeks.
DRUGCo-trimoxazole 20
Receive treatment with co-trimoxazole for 20 weeks.
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Thailand
Outcome results
None listed