Tuberculosis (TB) Infections and Infestations Tuberculosis
Conditions
Interventions
Control
Regimen 1: Standard TB treatment (isoniazid, rifampicin, pyrazinamide and ethambutol)
Interventions
Regimen 2: Isoniazid, rifampicin, pyrazinamide and gatifloxacin
Regimen 3: Isoniazid, rifam
Sponsors
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male/female of 18-65 years 2. Weight 38-80 kg 3. Recently microscopically diagnosed pulmonary TB 4. Findings in medical history and physical examination not exceeding grade 2 5. Voluntarily signed informed consent 6. Confirmed negative pregnancy test at the screening visit 7. Willing to use effective contraceptive methods during treatment 8. Normal lab values not exceeding grade 2, except haemoglobin grade 1) 9. Consent for a pre-screening biological test to exclude possible Multi Drug Resistant (MDR) TB and Negative MDR TB screen test will be a check if pre-screening biological test is done
Exclusion criteria
Exclusion criteria: 1. History of TB within the last 3 years 2. Concomitant infection requiring additional anti-infectious treatment (especially anti-retroviral medication [ARV]) 3. Human immunodeficiency virus (HIV) infected patients at World Health Organisation (WHO) stage 4 4. Diabetes mellitus or non insulin dependent diabetes mellitus requiring treatment 5. Drug and alcohol abuse 6. History of drug hypersensitivity and/or active allergic disease 7. Impaired renal, hepatic or gastric function that may interfere with drug absorption, distribution, metabolism or elimination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
South Africa
Outcome results
None listed