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| ID | Type | Description | Link |
|---|---|---|---|
| project number 542040 | Other Grant/Funding Number | Khon Kaen University | |
| 106698/B/14/Z | Other Grant/Funding Number | Wellcome Trust |
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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.
Planed interim analysis will be conducted when the patient enrollment reaches 600 cases for evaluating safety and futility of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-trimoxazole 12 | Active Comparator | Receive treatment with co-trimoxazole for 12 weeks. |
|
| Co-trimoxazole 20 | Experimental | Receive treatment with co-trimoxazole for 20 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-trimoxazole 12 | Drug | Receive treatment with co-trimoxazole for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 1-year non relapse rate | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Recurrence | Recurrent clinical features of melioidosis treated as such but not confirmed by positive culture. | 1 year |
| Treatment failure | Clinical decision to change treatment according to inadequate response to therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siriluck Anunnatsiri, MD | Khon Kaen Univerisity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khon Kaen Univerisity | Khon Kaen | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32725199 | Derived | Anunnatsiri S, Chaowagul W, Teparrukkul P, Chetchotisakd P, Tanwisaid K, Khemla S, Narenpitak S, Pattarapongsin M, Kongsawasd W, Pisuttimarn P, Thipmontree W, Mootsikapun P, Chaisuksant S, Chierakul W, Day NPJ, Limmathurotsakul D. A Comparison Between 12 Versus 20 Weeks of Trimethoprim-sulfamethoxazole as Oral Eradication Treatment for Melioidosis: An Open-label, Pragmatic, Multicenter, Non-inferiority, Randomized Controlled Trial. Clin Infect Dis. 2021 Dec 6;73(11):e3627-e3633. doi: 10.1093/cid/ciaa1084. |
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| ID | Term |
|---|---|
| D008554 | Melioidosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019121 | Burkholderia Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Co-trimoxazole 20 |
| Drug |
Receive treatment with co-trimoxazole for 20 weeks. |
|
| 9 weeks |
| Mortality | 1 year |
| Adverse Drug Reactions | Adverse events that are caused by the drug including drug allergy. | 9 weeks |
| Drug compliance | This will be done by interviewing and pill counting. | 12 or 20 weeks |
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |