|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
International Union Against Tuberculosis and Lung Diseases United States Agency for International Development (USAID) |
|---|---|
| Information provided by: | International Union Against Tuberculosis and Lung Diseases |
| ClinicalTrials.gov Identifier: | NCT00216333 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 1500 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | June 2007 |
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 :
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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 | |
| Study Director: | Christian Lienhardt, MD | International Union Against Tuberculosis and Lung Diseases |
More Information
| Study ID Numbers: | IUATLD CT Study C |
| Study First Received: | September 20, 2005 |
| Last Updated: | September 12, 2006 |
| ClinicalTrials.gov Identifier: | NCT00216333 |
| Health Authority: | France: IUATLD |
|
tuberculosis fixed dose combination DOT shot-course chemotherapy |
|
Bacterial Infections Gram-Positive Bacterial Infections Respiratory Tract Infections Respiratory Tract Diseases Tuberculosis, pulmonary |
Lung Diseases Tuberculosis, Pulmonary Mycobacterium Infections Tuberculosis |
|
Actinomycetales Infections |
