9 completed, 1 recruiting. 8 Phase 1, 1 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 7, Recruiting 1 |
| Phase 2 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 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 Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 6 hours), Sulbactam 20mg/kg-Durlobactam 20mg/kg (Every 8 hours), Sulbactam 25mg/kg -Durlobactam 25mg/kg (Every 8 hours) - Acinetobacter Baumannii-calcoaceticus Complex Infection (ABC) | Phase 1 | Recruiting | Innoviva Specialty Therapeutics | 48 | 2026-12-30 | 2026-10-06 |
| Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex Sulbactam, Durlobactam, Colistin - Acinetobacter Baumannii-calcoaceticus Complex, Hospital-acquired Bacterial Pneumonia | Phase 3 | Completed | Entasis Therapeutics | 207 | 2019-09-05 | 2023-02-01 |
| Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects ETX2514, 14C-ETX2514 - Acinetobacter Baumannii-calcoaceticus Complex Infections | Phase 1 | Completed | Entasis Therapeutics | 8 | 2019-06-21 | 2019-08-30 |
| Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers ETX2514, Placebo, moxifloxacin - Acinetobacter Baumannii-calcoaceticus Complex Infections | Phase 1 | Completed | Entasis Therapeutics | 32 | 2019-05-23 | 2019-08-30 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants ETX0282, Cefpodoxime proxetil, Placebo - Healthy Volunteers | Phase 1 | Completed | Entasis Therapeutics | 99 | 2018-03-16 | 2020-01-14 |
| Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections Sulbactam-ETX2514, Placebo, Imipenem-cilastatin - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 2 | Completed | Entasis Therapeutics | 80 | 2018-01-17 | 2020-01-22 |
| Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects ETX2514SUL - Acinetobacter Baumannii Infection | Phase 1 | Completed | Entasis Therapeutics | 34 | 2017-10-03 | 2018-06-14 |
| Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects ETX2514 and sulbactam - Healthy | Phase 1 | Completed | Entasis Therapeutics | 30 | 2017-08-21 | 2017-11-09 |
| Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects ETX2514, Placebo, Sulbactam - Acinetobacter Baumannii Infection | Phase 1 | Completed | Entasis Therapeutics | 124 | 2016-10-01 | 2017-06-05 |
| AZD0914 Phase 1 ADME Study in Healthy Volunteers AZD0914 - Healthy | Phase 1 | Completed | Entasis Therapeutics | 6 | 2015-01-01 | 2015-06-03 |
Infections (2) · Bacteremia (1) · Enterobacteriaceae Infections (1) · Renal Insufficiency (1)
durlobactam (6) · Sulbactam (4) · Cilastatin, Imipenem Drug Combination (2) · Cefpodoxime Proxetil (1) · Cilastatin (1) · Colistin (1) · Imipenem (1) · Moxifloxacin (1) · zoliflodacin (1)
United States (7) · Australia (2) · Belarus (1) · Brazil (1) · Bulgaria (1) · China (1) · Greece (1) · Hungary (1) · India (1) · Israel (1) · Lithuania (1) · Mexico (1) · Peru (1) · Puerto Rico (1) · Russia (1)
Anibal Calmaggi, MD (1) · Irene Mirkin, MD (1) · Jason Lickliter (1)
PMID 30126953, PMID 30373802, PMID 31843995, PMID 32284380, PMID 37182534