PanACEA - STEP2C -01

Recruiting Phase 2 Interventional Study
Pulmonary Tuberculosis Other Specified Pulmonary Tuberculosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
390 (estimated)
Sponsor
Michael Hoelscher · Other
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About This Trial
This is a phase 2B/C, open label platform study that will compare the efficacy, safety of experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental a…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provide written, informed consent prior to all trial-related procedures including HIV testing. 2. Male or female, aged between 18 and 65 years, inclusive. 3. Body weight (in light clothing and with no shoes) between 40 and 90 kg, inclusive. 4. Newly diagnosed, previously untr…
Contacts

Norbert Heinrich, PD Dr.

+49894400

Norbert.Heinrich@med.uni-muenchen.de

CONTACT

Ivan Noreña, MSc. MD

+49894400

Ivan.Norena@med.uni-muenchen.de

CONTACT