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
Recruitment status was Recruiting
Sponsor:
International Union Against Tuberculosis and Lung Diseases
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
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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 |
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 May 19, 2013