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

September 12, 2006 updated by: International Union Against Tuberculosis and Lung Diseases

International Multicenter Trial for the Evaluation of a Four-Drug Fixed Dose Combined Tablet Daily in the Initial Intensive Phase of Chemotherapy Followed by a Two-Drug Fixed Dose Combined Tablet Three Times a Week in the Continuation Phase for the Treatment of Pulmonary Tuberculosis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment

1500

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria
        • Not yet recruiting
        • Service de Pneumo-phtisiologie de Matiben
        • Contact:
        • Principal Investigator:
          • Noureddine Zidouni, MD
  • Bolivia
      • Santa Cruz, Bolivia
        • Recruiting
        • Program Nal. de Control de la Tuberculosis
        • Contact:
        • Sub-Investigator:
          • Segondo Guzman, MD
  • Colombia
      • Cali, Colombia
        • Recruiting
        • Centro Internacional de Entrenamiento
        • Contact:
        • Sub-Investigator:
          • Gustavo Montero, MD
  • Guinea
      • Conakry, Guinea
        • Recruiting
        • CHU Ignace Deen
        • Contact:
        • Sub-Investigator:
          • Boubacar BAH, MD
  • Mozambique
      • Manhica, Mozambique
        • Recruiting
        • Health Resesarch Center of Manhica
        • Contact:
        • Principal Investigator:
          • Mateu Espasa, MD
  • Nepal
      • Kathmandu, Nepal
        • Active, not recruiting
        • Nepal Anti-Tuberculosis Association
  • Peru
      • Lima, Peru
        • Recruiting
        • Grupo Levir S.A.
        • Contact:
          • Víctor Manuel Chávez Pérez, MD
          • Phone Number: +51-1-328-2451
          • Email: chzpz@viabcp.com
        • Sub-Investigator:
          • Eduardo Ticona, MD
  • Tanzania
      • Mwanza, Tanzania
        • Active, not recruiting
        • National Institute for Medical Research
  • Vietnam
      • Hanoi, Vietnam
        • Recruiting
        • National Hospital of TB and Respiratory Diseases
        • Contact:
        • Sub-Investigator:
          • Thuy Ha, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy : combined rate of failure at the end of treatment and relapse by 30 months.
Safety : occurrence of serious adverse events at any time during chemotherapy

Secondary Outcome Measures

Outcome Measure
Sputum culture results at two months of chemotherapy
Rate of completion of chemotherapy according to the protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Union Against Tuberculosis and Lung Diseases

Collaborators

United States Agency for International Development (USAID)

Investigators

  • Study Director: Christian Lienhardt, MD, International Union Against Tuberculosis and Lung Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

September 20, 2005

First Submitted That Met QC Criteria

September 20, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

September 13, 2006

Last Update Submitted That Met QC Criteria

September 12, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUATLD CT Study C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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