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)

ISRCTN	ISRCTN13670619
DOI	https://doi.org/10.1186/ISRCTN13670619
Protocol serial number	RPC078
Sponsor	UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Funder	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)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr T Kanyok
Scientific

20, Avenue Appia
Geneva -27
CH 1211
Switzerland

Email	kanyokt@who.int

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Tuberculosis (TB)
Intervention	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
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Gatifloxacin, moxifloxacin and ofloxacin, ethambutol, rifampicin, isoniazid and pyrazinamide
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Key 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
Key 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
Date of first enrolment	25/11/2004
Date of final enrolment	01/01/2006

20, Avenue Appia

Geneva -27
CH 1211
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan