Smear Positive Pulmonary Tuberculosis Clinical Trial
— AVDAPTOfficial title:
Phase 3 Trial of Oral L-arginine and / or Vitamin D as Adjunctive Therapies in Pulmonary Tuberculosis in Papua Province, Indonesia.
Verified date | January 2012 |
Source | Menzies School of Health Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ministry of Health |
Study type | Interventional |
The purpose of this study is to determine whether adjunctive L-arginine and vitamin D can improve response to standard short course TB therapy in people with newly diagnosed pulmonary TB.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
Inclusion Criteria: - Adults >15 years with sputum smear positive pulmonary TB - New cases only - Agree to continue treatment in Timika for the full six month course of treatment -Not pregnant - Consent to enroll in the study. Exclusion Criteria: - hypercalcaemia (ionized calcium >1.32 mmol/L) identified at baseline - taking arginine or vitamin D |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Timika Tuberculosis Clinic and Community Hospital | Timika | Papua Province |
Lead Sponsor | Collaborator |
---|---|
Menzies School of Health Research | Australian National University, National Institute of Health Research and Development (NIHRD), Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of pulmonary TB patients who are culture negative at 1 month | 1 month | No | |
Primary | Difference in improvement in composite clinical endpoint comprising weight, cough clearance and FEV1 at 2 months. | 2 months | No | |
Secondary | Change in plasma L-arginine concentration | week 0, 2, 4, 8, 24 | Yes | |
Secondary | Change in plasma 25(OH)D3 concentration | week 0, 2, 4, 8, 24 | Yes | |
Secondary | Death, clinical failure and default independently, and 'death or clinical failure or default'. | week 24 | Yes | |
Secondary | Hypercalcaemia | week 0, 2, 4, 8, 24 | Yes | |
Secondary | Gastrointestinal side effects | weekly to week 8 then at week 24 | Yes | |
Secondary | Sputum smear conversion time | weekly to week 8 then at week 24 | No | |
Secondary | Radiological improvement (percentage lung involvement on CXR at 2 months). | week 0, 2, 4, 8, 24 | No | |
Secondary | Cough clearance | weekly to week 8 then at week 24 | No | |
Secondary | Difference in improvement in percent predicted FEV1 at 2 and 6 months. | weeks 0, 4, 8, 24 | No | |
Secondary | Weight gain | weekly to week 8 then at week 24 | No | |
Secondary | Immunological improvement (exhaled NO) | week 0, 2, 4, 8, 24 | No | |
Secondary | Immunological improvement (T cell CD3? expression and T cell function) | week 0, 2, 4, 24 | No | |
Secondary | Functional improvement measured using six minute walk test | week 0, 4, 8, 24 | No | |
Secondary | Quality of life assessment using modified St George Respiratory Questionnaire. | weeks 0, 4, 8, 24 | No | |
Secondary | Primary end points stratified by HIV status. | weekly to week 8 then at week 24 | No | |
Secondary | Primary end points stratified by baseline vitamin D and L-arginine status. | weekly to week 8 then week 24 | No | |
Secondary | Primary end points stratified by ethnicity (Papuan and non-Papuan patients). | weekly to week 8 then week 24 | No |