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

September 20, 2005
September 12, 2006
December 2003
Not Provided
  • 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
  • - 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
Complete list of historical versions of study NCT00216333 on ClinicalTrials.gov Archive Site
  • Sputum culture results at two months of chemotherapy
  • Rate of completion of chemotherapy according to the protocol
  • - sputum culture results at two months of chemotherapy
  • - rate of completion of chemotherapy according to the protocol
Not Provided
Not Provided
 
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
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.

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)
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Tuberculosis
Drug: combined fixed dose combination
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
June 2007
Not Provided

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
Both
18 Years to 65 Years
No
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
Colombia,   Guinea,   Peru,   Mozambique,   Vietnam,   Tanzania,   Nepal,   Bolivia,   Algeria
 
NCT00216333
IUATLD CT Study C
Not Provided
Not Provided
International Union Against Tuberculosis and Lung Diseases
United States Agency for International Development (USAID)
Study Director: Christian Lienhardt, MD International Union Against Tuberculosis and Lung Diseases
International Union Against Tuberculosis and Lung Diseases
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP