9 completed, 2 terminated. 5 Phase 2, 4 Phase 3, 3 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 3, Terminated 2 |
| Phase 3 | 4 | Completed 3, Terminated 1 |
| Phase 1 | 3 | Completed 3 |
Follow solithromycin: new trials by email Literature Review of solithromycin trials Research Report on solithromycin
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 |
|---|---|---|---|---|---|---|
| Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia Solithromycin, Standard of Care - Community-acquired Bacterial Pneumonia | Phase 2 / Phase 3 | Terminated | Melinta Therapeutics, Inc. | 97 | 2016-04-01 | 2019-01-03 |
| Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis solithromycin - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Melinta Therapeutics, Inc. | 10 | 2015-12-01 | 2017-03-21 |
| A Study to Evaluate the Anti-inflammatory Effects of Solithromycin in Chronic Obstructive Pulmonary Disease Solithromycin, Placebo - Pulmonary Disease, Chronic Obstructive | Phase 2 | Terminated | Imperial College London | 6 | 2015-07-01 | 2019-12-30 |
| Genitourinary and Pharyngeal Pharmacokinetics of Solithromycin Solithromycin - Gonorrhoea | Phase 1 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 28 | 2015-05-05 | 2019-01-28 |
| Pharmacokinetics and Safety of Solithromycin in Adolescents and Children solithromycin - Bacterial Infection | Phase 1 | Completed | Melinta Therapeutics, Inc. | 84 | 2015-01-01 | 2017-06-09 |
| Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea solithromycin, ceftriaxone, azithromycin - Uncomplicated Urogenital Gonorrhea | Phase 3 | Completed | Melinta Therapeutics, Inc. | 264 | 2014-08-01 | 2017-09-11 |
| Pharmacokinetics and Safety of Solithromycin Capsules in Adolescents Solithromycin - Bacterial Infections | Phase 1 | Completed | Melinta Therapeutics, Inc. | 13 | 2013-12-01 | 2017-02-23 |
| Efficacy and Safety Study of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia Solithromycin, Moxifloxacin - Community-acquired Bacterial Pneumonia | Phase 3 | Completed | Melinta Therapeutics, Inc. | 863 | 2013-11-01 | 2017-03-03 |
| Efficacy and Safety Study of Oral Solithromycin (CEM-101) Compared to Oral Moxifloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia Solithromycin, Moxifloxacin, Placebo to match solithromycin - Community-acquired Bacterial Pneumonia | Phase 3 | Completed | Melinta Therapeutics, Inc. | 860 | 2012-12-01 | 2017-03-03 |
| Safety and Efficacy Study of Single-Dose Oral CEM-101 in Patients With Uncomplicated Urogenital Gonorrhea solithromycin, Solithromycin (CEM-101) - Uncomplicated Urogenital Gonorrhea | Phase 2 | Completed | Melinta Therapeutics, Inc. | 60 | 2012-05-01 | 2017-03-03 |
| Efficacy and Safety Study of Oral CEM-101 Compared to Oral Levofloxacin in Treatment of Patients With Community-Acquired Bacterial Pneumonia Levofloxacin, CEM-101 - Community-Acquired Bacterial Pneumonia | Phase 2 | Completed | Melinta Therapeutics, Inc. | 132 | 2010-08-01 | 2017-03-03 |
Pneumonia (3) · Bacterial Infections (2) · Gonorrhea (2) · Chlamydia Infections (1) · Inflammation (1) · Liver Diseases (1) · Non-alcoholic Fatty Liver Disease (1) · Pulmonary Disease, Chronic Obstructive (1)
Melinta Therapeutics, Inc. (9) · Imperial College London (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1)
United States (10) · Bulgaria (4) · Canada (3) · Hungary (3) · Spain (3) · Argentina (2) · Germany (2) · Latvia (2) · Philippines (2) · Poland (2) · Romania (2) · Russia (2) · South Africa (2) · United Kingdom (2) · Australia (1)
Michael Cohen-Wolkowiez, MD (2) · Brian D Jamieson, MD (1) · David Oldach, MD (1) · Edward W Hook, MD (1) · Marcus Chen, MD, PhD (1) · Michael Cohen-Wolkowiez, MD, PhD (1) · Peter J Barnes, FRS, FMedSci (1) · Robert Dobbins, MD, PhD (1) · William Man, MBBS, PhD (1)
PMID 29891609, PMID 31318840, PMID 23507282, PMID 26089222, PMID 26852726, PMID 26883693, PMID 27448679, PMID 31196813
2014 (1)