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 |
| Secondary identifying numbers | RPC078 |
- Submission date
- 07/04/2005
- Registration date
- 07/06/2005
- Last edited
- 26/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Dr T Kanyok
Scientific
Scientific
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| kanyokt@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Gatifloxacin, moxifloxacin and ofloxacin, ethambutol, rifampicin, isoniazid and pyrazinamide |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 25/11/2004 |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| 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 |
Locations
Countries of recruitment
- South Africa
- Switzerland
Study participating centre
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)
Other
Other
20, Avenue Appia
Geneva -27
CH 1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
