9 completed, 2 recruiting, 1 not yet recruiting, 1 unknown. 5 Phase 3, 4 Phase 2, 3 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Completed 4, Unknown 1 |
| Phase 2 | 4 | Recruiting 2, Completed 1, Not yet recruiting 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 4 | 2 | Completed 1, Withdrawn 1 |
Follow Cilastatin: new trials by email Literature Review of Cilastatin trials Research Report on Cilastatin
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 |
|---|---|---|---|---|---|---|
| Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria "Imipenem/cilastatin" and "Tigecycline", "colistin" and "meropenem" - MDR Bacteria | Phase 2 | Not yet recruiting | Ain Shams University | 60 | 2026-04-01 | 2026-04-13 |
| Prevention of Nephrotoxin-Induced Acute Kidney Injury Using Cilastatin Cilastatin Sodium, Placebo-Saline - Acute Kidney Injury | Phase 2 | Recruiting | Matthew James | 698 | 2025-07-16 | 2025-11-26 |
| A Double-blind Non Inferiority Clinical Trial to Compare the Nephroprotection of Cilastatn Versus Thiosulfate in Patients Undergoing Debulking Surgery With Intraoperative Hyperthermic Intraperitoneal Chemotherapy With Cisplatin. cilastatine, tiosulfate - Debulking Surgery for Ovarian Cancer, Acute Kidney Injury | Phase 2 | Recruiting | Hospital General Universitario Gregorio Marañon | 90 | 2025-02-21 | 2025-11-14 |
| Evaluation of the Efficacy and Safety of Intravenous Imipenem/Cilastatin/XNW4107 in Comparison With Meropenem in Hospitalized Adults With cUTI Including AP (EudraCT no. 2022-000061-40) Combination of Imipenem/Cilastatin and XNW4107, Meropenem - Complicated Urinary Tract Infection Including Acute Pyelonephritis | Phase 3 | Unknown | Evopoint Biosciences Inc. | 780 | 2023-03-30 | 2023-02-16 |
| Impact of Obesity on the Pharmacokinetics of Imipenem-Relebactam in ICU Patients Imipenem/Cilastatin/Relebactam 1.25g - Obesity, Critical Illness | Phase 4 | Withdrawn | University of Illinois at Chicago | 2023-01-01 | 2024-11-27 | |
| Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia (XNW4107-302, REITAB-2) Combination of Imipenem/Cilastatin and XNW4107, Imipenem/Cilastatin/Relebactam - Hospital Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia | Phase 3 | Completed | Evopoint Biosciences Inc. | 450 | 2022-07-31 | 2025-11-06 |
| Intrapulmonary Pharmacokinetics of XNW4107, Imipenem and Cilastatin in Healthy Subjects XNW4107, Imipenem/Cilastatin - Bacterial Infections | Phase 1 | Completed | Evopoint Biosciences Inc. | 21 | 2021-03-25 | 2023-02-16 |
| Pharmacokinetics of XNW4107 in Subjects With Various Degrees of Renal Function XNW4107, Imipenem/Cilastatin - Bacterial Infections | Phase 1 | Completed | Evopoint Biosciences Inc. | 39 | 2021-02-25 | 2023-02-16 |
| 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 |
| Safety, Tolerability and Pharmacokinetic Profile of an Infusion of Cilastatin in Healthy Volunteers. Cilastatin, Placebo - Dose Finding Study | Phase 1 | Completed | Spherium Biomed | 23 | 2018-06-19 | 2018-10-09 |
| Imipenem/Relebactam/Cilastatin Versus Piperacillin/Tazobactam for Treatment of Participants With Bacterial Pneumonia (MK-7655A-014) Imipenem, Relebactam, Cilastatin - Bacterial Pneumonia | Phase 3 | Completed | Merck Sharp & Dohme LLC | 537 | 2015-11-24 | 2020-04-16 |
| Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003) Relebactam 250 mg, Relebactam 125 mg, imipenem/cilastatin 500 mg - Urinary Tract Infections, Pyelonephritis | Phase 2 | Completed | Merck Sharp & Dohme LLC | 302 | 2012-05-16 | 2019-05-24 |
| A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092) MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days, Comparator: amikacin / Duration of Treatment: 3 Days, Comparator: tazocin / Duration of Treatment: 3 Days - Infection, Pneumonia | Phase 4 | Completed | Merck Sharp & Dohme LLC | 120 | 2006-11-01 | 2017-02-17 |
| Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia Tigecycline, Imipenem, Cilastatin - Bacterial Pneumonia | Phase 3 | Completed | Wyeth is now a wholly owned subsidiary of Pfizer | 430 | 2003-07-01 | 2008-08-04 |
Acute Kidney Injury (2) · Bacterial Infections (2) · Pneumonia (2) · Pneumonia, Bacterial (2) · Bacteremia (1) · Critical Illness (1) · Infections (1) · Obesity (1) · Pyelonephritis (1) · Urinary Tract Infections (1) · Urologic Diseases (1)
Evopoint Biosciences Inc. (4) · Merck Sharp & Dohme LLC (3) · Ain Shams University (1) · Entasis Therapeutics (1) · Hospital General Universitario Gregorio Marañon (1) · Matthew James (1) · Spherium Biomed (1) · University of Illinois at Chicago (1) · Wyeth is now a wholly owned subsidiary of Pfizer (1)
United States (7) · Spain (3) · Israel (2) · Belarus (1) · Brazil (1) · Canada (1) · China (1) · Egypt (1) · France (1) · Greece (1) · Hungary (1) · India (1) · Lithuania (1) · Mexico (1) · Peru (1)
Jason Le (3) · Matthew T James, MD (1)
PMID 18436554, PMID 28575389, PMID 32785589, PMID 34704389, PMID 37182534, PMID 37383243, PMID 40536823, PMID 41143893, PMID 41586496, PMID 42294651, PMID 42657892, PMID 42743113
2015 (1), 2017 (1)