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)

Completed

Conditions: Tuberculosis
Tuberculosis (TB)
Infections and Infestations

Registration Number: ISRCTN13670619

Lead Sponsor: ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 0

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