FHI Clinical CSM application portal

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Applications List

CSM Demo
Application that serves as a demonstration of the CSM capabilities. Used as the base application for trial-specific CSM applications.
04 April 2023
Release Date
CSM PanACEA-Step2-01
A multiple arm, multiple stage (MAMS), phase 2B/C, open label, randomized, controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin and sutezolid, in adults with newly diagnosed, drug sensitive , smear-positive pulmonary tuberculosis
18 July 2023
Release Date
CSM AUR1‐1‐313 DRTB‐HDT
A randomized controlled trial of two adjunctive host‐directed therapies in rifampin‐resistant tuberculosis
8 August 2023
Release Date
CSM Biofabri MTBVAC203
Randomised, Double-blind Controlled Phase 3 Trial to Evaluate the Efficacy , Safety, and Immunogenicity of MTBVAC Administered in Healthy HIV Unexposed and HIV Exposed Uninfected Newborns in Tuberculosis-endemic Regions of Sub-Saharan Africa.
22 August 2023
Release Date
CSM AUR1‐6‐352 1 to 3
A randomized trial comparing treatment completion of daily rifapentine & Isoniazid for one month (1HP) to weekly Rifapentine & Isoniazid for 3 months (3HP) in persons living with HIV and in HIV-negative household contacts of recently diagnosed Tuberculosis patients, the “One to Three” trial.
20 September 2023
Release Date
CSM Dolphin Kids
Safety, tolerability and drug-drug interactions of short-course tuberculosis preventive treatment with high-dose once-weekly rifapentine and isoniazid (3HP) among Infants, Children and Adolescents Living with HIV taking dolutegravir-based antiretroviral treatment.
19 October 2023
Release Date
CSM BTZ-043 Decision
A Phase IIb, Open-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-Response Relationship of different doses of BTZ-043 in combination with Bedaquiline and Delamanid in Adult Subjects with Newly Diagnosed, Uncomplicated, Drug-sensitive Pulmonary Tuberculosis.
23 January 2024
Release Date
CSM AUR1-6-351 Dolphin Moms
Safety and tolerability of 1 month daily (1HP) and 3 months weekly (3HP) isoniazid and rifapentine with pharmacokinetics of dolutegravir (DTG) in pregnant people with HIV.
08 March 2024
Release Date