An evaluation of two eight-month regimens of chemotherapy for the treatment of newly diagnosed pulmonary tuberculosis

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN19832141
• Date of registration: 15/04/2010
• Prospective Registration: No
• Primary sponsor: International Union Against Tuberculosis and Lung Disease (France)
• Public title: An evaluation of two eight-month regimens of chemotherapy for the treatment of newly diagnosed pulmonary tuberculosis
• 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
• Date of first enrolment: 01/03/1998
• Target sample size: 1500
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN19832141
• Study type: Interventional
• Study design: Multicentre randomised single-blind controlled trial (Treatment)

Countries of recruitment

Benin, China, Guinea, Mozambique, Nepal, Tanzania

Contacts

• Name: Donald Enarson

Key inclusion & exclusion criteria

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
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Smear-positive pulmonary tuberculosis
Infections and Infestations
Respiratory tuberculosis, bacteriologically and histologically confirmed

Intervention(s)

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

Primary Outcome(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

Secondary Outcome(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

Secondary ID(s)

N/A

Source(s) of Monetary Support

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)