7 completed, 1 active not recruiting, 1 withdrawn. 6 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 6 | Completed 4, Active not recruiting 1, Withdrawn 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 3 | 1 | Active not recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Pan-TB Regimen Targeting Host and Microbe Sutezolid, N-acetyl cysteine, Pretomanid - Tuberculosis | Phase 2 / Phase 3 | Active not recruiting | The Aurum Institute NPC | 352 | 2023-07-28 | 2025-05-28 |
| PanACEA Sutezolid Dose-finding and Combination Evaluation Sutezolid, Bedaquiline, Delamanid, Moxifloxacin, Midazolam oral solution - Pulmonary Tuberculosis, Other Specified Pulmonary Tuberculosis | Phase 2 | Completed | Michael Hoelscher | 75 | 2021-05-06 | 2023-05-01 |
| Evaluation of SQ109, High-dose Rifampicin, and Moxifloxacin in Adults With Smear-positive Pulmonary TB in a MAMS Design SQ109, Rifampicin, Moxifloxacin - Tuberculosis, Pulmonary | Phase 2 | Completed | Michael Hoelscher | 365 | 2013-04-01 | 2017-09-20 |
| Evaluation of SQ109 Plus PPI in Urea Breath Test-Positive Volunteers SQ109 - Helicobacter Pylori Infection | Phase 2 | Withdrawn | Sequella, Inc. | 2012-03-01 | 2015-11-17 | |
| PNU-100480 In Newly Diagnosed, Drug Sensitive Patients With Pulmonary TB; Early Bactericidal Activity; Whole Blood Assay PNU-100480, RHZE - Tuberculosis | Phase 2 | Completed | Sequella, Inc. | 59 | 2011-08-01 | 2016-01-14 |
| Early Bactericidal Activity (EBA) of SQ109 in Adult Subjects With Pulmonary TB SQ109, Rifampicin - Tuberculosis, Pulmonary | Phase 2 | Completed | Michael Hoelscher | 90 | 2010-11-01 | 2013-01-14 |
| Safety, Tolerability, Pharmacokinetics And Measurement Of Whole Blood Activity (WBA) Of PNU-100480 After Multiple Oral Doses In Healthy Adult Volunteers PNU-100480, Placebo, Linezolid - Tuberculosis | Phase 1 | Completed | Sequella, Inc. | 59 | 2009-10-01 | 2013-08-28 |
| Safety, Tolerability And Pharmacokinetics Study Of Single Doses Of PNU-100480 In Healthy Adults PNU-100480, Placebo - Tuberculosis | Phase 1 | Completed | Sequella, Inc. | 19 | 2009-04-01 | 2013-08-27 |
| Escalating Single-dose Safety, Tolerability, and Pharmacokinetics of SQ109 in Healthy Volunteers SQ109 - Tuberculosis | Phase 1 | Completed | Sequella, Inc. | 62 | 2006-09-01 | 2013-08-19 |
Tuberculosis (8) · Tuberculosis, Pulmonary (3) · Gram-Positive Bacterial Infections (1) · Peptic Ulcer (1) · Stomach Neoplasms (1) · Stomach Ulcer (1)
PNU-100480 (5) · Moxifloxacin (2) · Rifampin (2) · bedaquiline (2) · Acetylcysteine (1) · Ethambutol (1) · Isoniazid (1) · Linezolid (1) · Midazolam (1) · OPC-67683 (1) · Pyrazinamide (1) · Pyridoxine (1) · pretomanid (1)
South Africa (5) · Tanzania (3) · United States (3) · Mozambique (1)
Lisa Beth Ferstenberg, M.D. (3) · Michael Hoelscher, MD (2) · Andreas Diacon, MD (1) · Frank Lanza, MD (1) · Martin Boeree, MD (1) · Michael Hoelscher, Prof. (1) · Professor Robert Wallis, MD (1) · Rodney Dawson, MD (1)
PMID 20629533, PMID 24732289, PMID 28100438, PMID 33542052, PMID 40645196, PMID 41749341