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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2006 by International Union Against Tuberculosis and Lung Diseases.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by:
International Union Against Tuberculosis and Lung Diseases
ClinicalTrials.gov Identifier:
NCT00216333
First received: September 20, 2005
Last updated: September 12, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Tuberculosis
Drug: combined fixed dose combination
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by International Union Against Tuberculosis and Lung Diseases:

Primary Outcome Measures:
  • 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:
  • Sputum culture results at two months of chemotherapy
  • Rate of completion of chemotherapy according to the protocol

Estimated Enrollment: 1500
Study Start Date: December 2003
Estimated Study Completion Date: June 2007
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)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00216333

Contacts
Contact: Sharlette Cook, MPH +33 1 44 32 06 47 scook@iuatld.org
Contact: Christian Lienhardt, MD + 33 1 44 32 06 43 ext 06 43 clienhardt@iuatld.org

Locations
Algeria
Service de Pneumo-phtisiologie de Matiben Not yet recruiting
Algiers, Algeria
Contact: Noureddine Zidouni, MD    213-21 93 13 86    nzidouni@sante.dz   
Principal Investigator: Noureddine Zidouni, MD         
Bolivia
Program Nal. de Control de la Tuberculosis Recruiting
Santa Cruz, Bolivia
Contact: Mirtha Camacho, MD    59122211275    tbcos@hotmail.com   
Sub-Investigator: Segondo Guzman, MD         
Colombia
Centro Internacional de Entrenamiento Recruiting
Cali, Colombia
Contact: Dr Juan Francisco Miranda, MD    57 2 668 2164    mirandaf@cideim.org.co   
Sub-Investigator: Gustavo Montero, MD         
Guinea
CHU Ignace Deen Recruiting
Conakry, Guinea
Contact: Mamadou D BARRY, MD    224 29 86 40    mdtelibarry@yahoo.fr   
Sub-Investigator: Boubacar BAH, MD         
Mozambique
Health Resesarch Center of Manhica Recruiting
Manhica, Mozambique
Contact: Mateu Dr Mateu Espasa, MD    + 258 1 81 01 81    mateu.espasa@manhica.net   
Principal Investigator: Mateu Espasa, MD         
Nepal
Nepal Anti-Tuberculosis Association Active, not recruiting
Kathmandu, Nepal
Peru
Grupo Levir S.A. Recruiting
Lima, Peru
Contact: Víctor Manuel Chávez Pérez, MD    +51-1-328-2451    chzpz@viabcp.com   
Sub-Investigator: Eduardo Ticona, MD         
Tanzania
National Institute for Medical Research Active, not recruiting
Mwanza, Tanzania
Vietnam
National Hospital of TB and Respiratory Diseases Recruiting
Hanoi, Vietnam
Contact: Sy Dinh Ngoc, MD, PhD    0913284158    vnntp463@hn.vnn.vn   
Sub-Investigator: Thuy Ha, MD         
Sponsors and Collaborators
International Union Against Tuberculosis and Lung Diseases
United States Agency for International Development (USAID)
Investigators
Study Director: Christian Lienhardt, MD International Union Against Tuberculosis and Lung Diseases
  More Information

No publications provided by International Union Against Tuberculosis and Lung Diseases

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00216333     History of Changes
Other Study ID Numbers: IUATLD CT Study C
Study First Received: September 20, 2005
Last Updated: September 12, 2006
Health Authority: France: IUATLD

Keywords provided by International Union Against Tuberculosis and Lung Diseases:
tuberculosis
fixed dose combination
DOT
shot-course chemotherapy

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014