Tuberculosis Clinical Trial
Official title:
Studying the Blood Levels of First-line Anti-tuberculosis Drugs in Relation to Treatment Outcomes Among Newly Diagnosed Adults With Pulmonary Tuberculosis on the Thai-Myanmar Border
Verified date | October 2018 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border. This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per WHO guidelines.
Status | Completed |
Enrollment | 61 |
Est. completion date | January 14, 2018 |
Est. primary completion date | January 14, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Clinical and microbiogical diagnosis of pulmonary TB 2. Males and females aged >18 years old 3. Willing to comply with study procedures including residing in the TB centre or nearby for six months 4. Written informed consent provided by participant Exclusion Criteria: 1. TB treatment in the past 2. Known or suspected pregnancy 3. Enrolled for TB treatment at one of the study sites 4. Known hypersensitivity/intolerance to one or more of anti-TB drugs 5. The MTB strain that shown resistant to Rifampicin, which is the precursor marker of MDR TB detected by a MTB/Rif Xpert Assay 6. Biochemistry test result: 1. Creatinine > 3 x upper limit of normal (ULN) 2. bilirubin > 2.5 x ULN 3. AST and/or ALT > 5 x ULN 7. Refuse to take HIV testing 8. The diagnosed TB patients who choose to take the treatment at a Thai hospital or a hospital in Myanmar 9. The proven non-TB patients by clinical and microbiological diagnosis. |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma drug levels of Rifampicin | Rifampicin, Isoniazid, Pyrazinamide and Ethambutol in different study groups | 6 Months | |
Primary | Plasma drug levels of Isoniazid | 6 Months | ||
Primary | Plasma drug levels of Pyrazinamide | 6 Months | ||
Primary | Plasma drug levels of Ethambutol | 6 Month | ||
Secondary | Time to negativity of M. tuberculosis | Time to negativity of M. tuberculosis in relation to drug | 6 Months | |
Secondary | Genotyping MTB strains | Genotyping MTB strains in order to see any infection with new wild MTB or mutant strain in the study population | 6 Months |
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