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
Secondary identifying numbers	N/A

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

International Union Against Tuberculosis and Lung Disease
Paris
75006
France

Study information

Study design	Multicentre randomised single-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient 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	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 study start date	01/03/1998
Completion date	01/12/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1,500
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

Sponsor information

International Union Against Tuberculosis and Lung Disease (France)
Charity

68 Boulevard Saint-Michel
Paris
75006
France

Website	http://www.theunion.org
"ROR"	https://ror.org/037x4qk98

Funders

Funder type

Other

Ministry of Foreign Affairs - Directorate of Development and Technical Cooperation (Ministère des Affaires Etrangères - Direction du Développement et de la Coopération Technique) (France)

No information available

The Norwegian Heart & Lung Association (Norway)

No information available

Norwegian Agency for Development Cooperation (NORAD) (Norway)

No information available

US Agency for International Development (USAID) (USA)

No information available

Trustees of the Royal Free Hospital (UK)

No information available

Kuratorium Tuberkulose in der Welt e.V (Germany)

No information available

Hoechst Marion Roussel S.p.A. (Italy)

No information available

Fatol Arzneimittel GmbH (Germany)

No information available

Bracco S.p.A. (Italy)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2004		Yes	No