Recruitment Status:
Pending
Project Description:
Multidrug-resistant tuberculosis (MDR-TB) is tuberculosis (TB) that is resistant to at least isoniazid and rifampicin, the two most important anti-TB drugs. It occurs in 3.6% of newly diagnosed TB patients in the world and 17% of patients who have been previously treated. In 2017, approximately 6 . . .
Primary Sponsor:
De La Salle Medical and Health Sciences Institute
Study Type:
Interventional
Date of Registration:
23 June 2021
Date of FIrst Enrollment:
01 July 2021
Method of Allocation:
Randomized
FDA Clinical Trial Reference (CTR) Number:
2021-CT0603
Sources of Monetary or Material Support:
University of California, San Francisco
Primary Outcomes:
Treatment Efficacy - Frequency of "successful treatment" outcomes [ Time Frame: Week 76 ]
A participant's outcome will be classified as successful if, at 76 weeks after initiation of treatment, they have a "negative" sputum culture and were not previously . . .
Key Inclusion and Exclusion Criteria:
Inclusion Criteria:
Males and females age ≥12 years. Prior to study procedures, if ≥18 years of age, provides informed consent; if
Has pulmonary TB based on investigator assessment of all available information (e.g., chest radiograph, sputum smear, culture, molecular . . .
Countries of Recruitment:
Philippines, Vietnam, Malaysia, Peru, Philippines, China, Denmark, France, Germany, Hungary, India, Italy, Japan, Mexico, Peru, Philippines, Romania, Russia, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Health Condition(s) or Problem(s) Studied:
Tuberculosis, Multidrug-Resistant