Melioidosis Infections and Infestations Melioidosis
Conditions
Interventions
The patients will be randomised into two groups, and the randomisation will be performed in advance by blocks of ten. Pre-prepared treatment-containing packs will be labelled with the consecutive stud
Sponsors
Khon Kaen University (Thailand)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Culture-confirmed melioidosis 2. Satisfactory completion of intravenous therapy and able to take oral medication 3. Patients with mild localised disease who are not considered to require intravenous treatment by their primary physician are eligible if they agree to return for follow up 5. Aged over 14 years, either sex 6. High likelihood of completing at least six months follow up 7. Willingness to participate in the study and written, informed consent obtained from the patient
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding 2. Contraindications to doxycycline: severe hepatic impairment (aspartate aminotransferase [AST], alanine aminotransferase [ALT] more than or equal to five times of upper limit of normal) 3. Contraindications to TMP-SMX: Glucose-6-phosphate dehydrogenase (G6PD) deficiency, renal impairment (creatinine clearance less than 15 ml/min) 4. History of hypersensitivity to doxycycline, TMP or SMX 5. Infecting isolate is resistant to TMP-SMX by E-test 6. Relapse melioidosis with disease free interval of less than two years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mortality 2. Recurrent disease: this is defined as clinical features of melioidosis after initial improvement, in association with cultures from any site positive for Burkholderia pseudomallei. This can be any time point during or after stopping antibiotic treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical recurrence: recurrent clinical features of melioidosis treated as such but not confirmed by positive culture 2. Treatment failure: clinical decision to change treatment according to inadequate response to therapy 3. Adverse drug reactions, including drug allergy 4. Drug compliance: based on interview and pill counting | — |
Countries
Thailand
Outcome results
None listed