A Phase 4 interventional study of combined fixed dose combination in Tuberculosis, sponsored by International Union Against Tuberculosis and Lung Diseases. Status unknown at 9 sites in 9 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-09-13.
Sponsored by International Union Against Tuberculosis and Lung Diseases · Phase 4, Interventional, and Treatment
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 :
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's enrollment of 1,500 is above the median of 150 across 820 interventional studies indexed under Tuberculosis.
Browse Tuberculosis studies →This is the only study on the registry with International Union Against Tuberculosis and Lung Diseases as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Sputum culture results at two months of chemotherapy
Rate of completion of chemotherapy according to the protocol
The record gives a start of Dec 2003 and a completion of Jun 2007. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2006. You cannot join it, but the record below documents what was studied.
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