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Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis

NCT ID: NCT00216333

Last Updated: 2006-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2007-06-30

Brief Summary

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The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disease (The Union) and the World Health Organisation. The advantages of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. Recent bioavailability studies of four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by four months treatment with a two-drug FDC of rifampicin and isoniazid.

Detailed Description

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This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined FDC regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs.

Patients will be allocated at random either :

* an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose COMBINED tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2COMB/4(RH)3) or
* the same drugs given in SEPARATE formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2SEPA/4(RH)3)

Conditions

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Tuberculosis

Keywords

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tuberculosis fixed dose combination DOT shot-course chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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combined fixed dose combination

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with newly diagnosed pulmonary tuberculosis
* two sputum specimens positive for acid-fast bacilli on direct smear microscopy
* no previous anti-tuberculosis chemotherapy
* aged 18 years and over
* firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
* agree to participate in the study and to give a sample of blood for HIV test

Exclusion Criteria

* patients in a moribund state,
* TB meningitis,
* pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
* pregnancy or breast feeding,
* psychiatric illness
* alcoholism
* contraindication to any medications in the study regimens
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Agency for International Development (USAID)

FED

Sponsor Role collaborator

International Union Against Tuberculosis and Lung Diseases

OTHER

Sponsor Role lead

Principal Investigators

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Christian Lienhardt, MD

Role: STUDY_DIRECTOR

International Union Against Tuberculosis and Lung Diseases

Locations

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Service de Pneumo-phtisiologie de Matiben

Algiers, , Algeria

Site Status NOT_YET_RECRUITING

Program Nal. de Control de la Tuberculosis

Santa Cruz, , Bolivia

Site Status RECRUITING

Centro Internacional de Entrenamiento

Cali, , Colombia

Site Status RECRUITING

CHU Ignace Deen

Conakry, , Guinea

Site Status RECRUITING

Health Resesarch Center of Manhica

Manhiça, , Mozambique

Site Status RECRUITING

Nepal Anti-Tuberculosis Association

Kathmandu, , Nepal

Site Status ACTIVE_NOT_RECRUITING

Grupo Levir S.A.

Lima, , Peru

Site Status RECRUITING

National Institute for Medical Research

Mwanza, , Tanzania

Site Status ACTIVE_NOT_RECRUITING

National Hospital of TB and Respiratory Diseases

Hanoi, , Vietnam

Site Status RECRUITING

Countries

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Algeria Bolivia Colombia Guinea Mozambique Nepal Peru Tanzania Vietnam

Central Contacts

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Sharlette Cook, MPH

Role: CONTACT

Phone: +33 1 44 32 06 47

Email: [email protected]

Christian Lienhardt, MD

Role: CONTACT

Phone: + 33 1 44 32 06 43

Email: [email protected]

Facility Contacts

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Noureddine Zidouni, MD

Role: primary

Mirtha Camacho, MD

Role: primary

Dr Juan Francisco Miranda, MD

Role: primary

Mamadou D BARRY, MD

Role: primary

Mateu Dr Mateu Espasa, MD

Role: primary

Víctor Manuel Chávez Pérez, MD

Role: primary

Sy Dinh Ngoc, MD, PhD

Role: primary

References

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Lienhardt C, Cook SV, Burgos M, Yorke-Edwards V, Rigouts L, Anyo G, Kim SJ, Jindani A, Enarson DA, Nunn AJ; Study C Trial Group. Efficacy and safety of a 4-drug fixed-dose combination regimen compared with separate drugs for treatment of pulmonary tuberculosis: the Study C randomized controlled trial. JAMA. 2011 Apr 13;305(14):1415-23. doi: 10.1001/jama.2011.436.

Reference Type DERIVED
PMID: 21486974 (View on PubMed)

Other Identifiers

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IUATLD CT Study C

Identifier Type: -

Identifier Source: org_study_id