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ISRCTN
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ISRCTN13670619
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ClinicalTrials.gov identifier
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Public title
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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)
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Scientific title
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Acronym
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N/A
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Serial number at source
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RPC078
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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South Africa
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Disease/condition/study domain
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Tuberculosis (TB)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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25/11/2004
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Anticipated end date
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01/01/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Control
Regimen 1: Standard TB treatment (isoniazid, rifampicin, pyrazinamide and ethambutol)
Interventions
Regimen 2: Isoniazid, rifampicin, pyrazinamide and gatifloxacin
Regimen 3: Isoniazid, rifampicin, pyrazinamide and ofloxacin
Regimen 4: Isoniazid, rifampicin, pyrazinamide and moxifloxacin
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
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Trial website
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Publications
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Contact name
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Dr
T
Kanyok
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Address
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20, Avenue Appia
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City/town
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Geneva -27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Email
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kanyokt@who.int
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Sponsor
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UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
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Address
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20, Avenue Appia
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City/town
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Geneva -27
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Zip/Postcode
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CH 1211
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Country
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Switzerland
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Sponsor website:
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http://www.who.int
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Date applied
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07/04/2005
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Last edited
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26/03/2008
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Date ISRCTN assigned
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07/06/2005
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