Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study A
Study hypothesis
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
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
Study design
Multicentre randomised single-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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
Overall trial start date
01/03/1998
Overall trial end date
01/12/2001
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1,500
Participant 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
Recruitment start date
01/03/1998
Recruitment end date
01/12/2001
Locations
Countries of recruitment
Benin, China, Guinea, Mozambique, Nepal, Tanzania
Trial participating centre
International Union Against Tuberculosis and Lung Disease
Paris
75006
France
Sponsor information
Organisation
International Union Against Tuberculosis and Lung Disease (France)
Sponsor details
68 Boulevard Saint-Michel
Paris
75006
France
Sponsor type
Charity
Website
Funders
Funder type
Other
Funder name
Ministry of Foreign Affairs - Directorate of Development and Technical Cooperation (Ministère des Affaires Etrangères - Direction du Développement et de la Coopération Technique) (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Norwegian Heart & Lung Association (Norway)
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Location
Funder name
Norwegian Agency for Development Cooperation (NORAD) (Norway)
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US Agency for International Development (USAID) (USA)
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Trustees of the Royal Free Hospital (UK)
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Funder name
Kuratorium Tuberkulose in der Welt e.V (Germany)
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Hoechst Marion Roussel S.p.A. (Italy)
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Fatol Arzneimittel GmbH (Germany)
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Funder name
Bracco S.p.A. (Italy)
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Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15464185
Publication citations
-
Results
Jindani A, Nunn AJ, Enarson DA, Two 8-month regimens of chemotherapy for treatment of newly diagnosed pulmonary tuberculosis: international multicentre randomised trial., Lancet, 364, 9441, 1244-1251, doi: 10.1016/S0140-6736(04)17141-9.