Condition category
Infections and Infestations
Date applied
06/04/2010
Date assigned
15/04/2010
Last edited
15/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Donald Enarson

ORCID ID

Contact details

International Union Against Tuberculosis and Lung Disease
Paris
75006
France

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 measures

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

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

http://www.theunion.org

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)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Norwegian Agency for Development Cooperation (NORAD) (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

US Agency for International Development (USAID) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Trustees of the Royal Free Hospital (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Kuratorium Tuberkulose in der Welt e.V (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fatol Arzneimittel GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bracco S.p.A. (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15464185

Publication citations

  1. 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.

Additional files

Editorial Notes