ISRCTN13670619CompletedNot Applicable
A comparative study of the bactericidal and sterilising activity of three fluoroquinolones: gatifloxacin, moxifloxacin and ofloxacin substituted for ethambutol in the two month initial phase of the standard anti-tuberculosis treatment regimen also containing rifampicin, isoniazid and pyrazinamide (South Africa)
ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)0 sites0 target enrollmentStarted: June 7, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 <6.5 g/dl and potassium <3.0 mEq/l (>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
- •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
Investigators
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