Cerba Research performed an open-label, partially randomized trial to evaluate the efficacy, safety and tolerability of a 4-month combined treatment compared to a 6-month control treatment in adult participants with drug-sensitive smear-positive pulmonary tuberculosis (DS TB) and a 6-month treatment in adult participants with drug-resistant, smear-positive pulmonary tuberculosis (DR-TB)
Many sites lacked materials to perform monovenopuncture collection. In addition, high patient screening and enrolment rates made it hard for sites to manage kit supplies. Lastly, while all clinical reports were shared with the investigator, no system existed that alerted investigators of alert values.
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Case Study – Phase 2c Clinical Trial on the Efficacy, Safety and Tolerability of Drug-Sensitive Smear-Positive Pulmonary Tuberculosis (DS TB) Treatment
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