An evaluation of two eight-month regimens of chemotherapy for the treatment of newly diagnosed pulmonary tuberculosis
| ISRCTN | ISRCTN19832141 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19832141 |
| Protocol serial number | N/A |
| Sponsor | International Union Against Tuberculosis and Lung Disease (France) |
| Funders | Ministry of Foreign Affairs - Directorate of Development and Technical Cooperation (Ministère des Affaires Etrangères - Direction du Développement et de la Coopération Technique) (France), The Norwegian Heart & Lung Association (Norway), Norwegian Agency for Development Cooperation (NORAD) (Norway), US Agency for International Development (USAID) (USA), Trustees of the Royal Free Hospital (UK), Kuratorium Tuberkulose in der Welt e.V (Germany), Hoechst Marion Roussel S.p.A. (Italy), Fatol Arzneimittel GmbH (Germany), Bracco S.p.A. (Italy) |
- Submission date
- 06/04/2010
- Registration date
- 15/04/2010
- Last edited
- 15/04/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Donald Enarson
Scientific
Scientific
International Union Against Tuberculosis and Lung Disease
Paris
75006
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised single-blind controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An evaluation of two eight-month regimens of chemotherapy for the treatment of newly diagnosed pulmonary tuberculosis: A multicentre, single-blinded, randomised controlled trial |
| Study acronym | Study A |
| Study objectives | An 8-month regimen for the treatment of pulmonary tuberculosis with either a daily or three times weekly initial intensive phase is not inferior to a six month standard treatment regimen |
| Ethics approval(s) | The study protocol was reviewed and approved by the Ethics Advisory Group of The International Union Against Tuberculosis and Lung Disease, approved on the 1st of December 2000 and one year thereafter |
| Health condition(s) or problem(s) studied | Smear-positive pulmonary tuberculosis |
| Intervention | Participants from 8 sites with smear positive pulmonary tuberculosis who had never previously treated were randomly assigned from a table of random numbers to one of three treatment regimens: 1. Intensive Initial Treatment: 2 months of daily isoniazid, rifampicin, pyrazinamide and ethambutol followed by 6 months of daily isoniazid and ethambutol 2. Intermittant Initial Treatment: 2 months of thrice-weekly isoniazid, rifampicin, pyrazinamide and ethambutol followed by 6 months of daily isoniazid and ethambutol 3. Standard Treatment: 2 months of daily isoniazid, rifampicin, pyrazinamide and ethambutol followed by 4 months of daily isoniazid and rfampicin |
| Intervention type | Other |
| Primary outcome measure(s) |
The proportion of patients with negative cultures at two months and the status of patients 12 months after completion of chemotherapy (i.e. at 18 or 20 months after start of chemotherapy depending on the regimen). The two-month culture result was chosen to compare the rate of sputum conversion of the three times weekly intensive phase with that of the daily intensive phase |
| Key secondary outcome measure(s) |
The proportion of failures at the end of chemotherapy (at 6 or 8 months after start of chemotherapy) and the proportion patients with adverse events requiring stopping of their chemotherapy or an interruption of treatment for 7 days or more |
| Completion date | 01/12/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1500 |
| Key inclusion criteria | 1. Age 15 to 65 years 2. Two sputum specimens positive for acid-fast bacilli on direct smear microscopy 3. No previous anti-tuberculosis chemotherapy for more than one month 4. A specific home address readily accessible for visiting in case of a failure to attend 5. Informed consent given and agreed to participate in the study and to give a sample of blood, urine or saliva for HIV testing |
| Key exclusion criteria | 1. So ill they were thought unlikely to survive the initial weeks of treatment 2. Presence of extra-pulmonary tuberculosis 3. Concomitant diseases likely to prejudice the response to, or assessment of, treatment such as 3.1. Diabetes 3.2. Liver disease 3.3. Nephritis 3.4. Blood disorders 3.5. Epilepsy 3.6. Peripheral neuritis 4. Known to be pregnant 5. Suffering from a psychiatric illness or alcoholism |
| Date of first enrolment | 01/03/1998 |
| Date of final enrolment | 01/12/2001 |
Locations
Countries of recruitment
- Benin
- China
- France
- Guinea
- Mozambique
- Nepal
- Tanzania
Study participating centre
International Union Against Tuberculosis and Lung Disease
Paris
75006
France
75006
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2004 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
