30 completed, 5 withdrawn, 2 not yet recruiting, 1 terminated. 30 Phase 1, 7 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 30 | Completed 27, Withdrawn 3 |
| Phase 3 | 7 | Completed 2, Withdrawn 2, Not yet recruiting 1, Terminated 1, Unknown 1 |
| Phase 2 | 2 | Completed 1, Not yet 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 |
|---|---|---|---|---|---|---|
| Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia Cefepime-Zidebactam, Ceftazidime-avibactam with or without Colistin - Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP) | Phase 3 | Not yet recruiting | Wockhardt | 324 | 2026-10-28 | 2026-10-21 |
| This is a Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Ertapenem-zidebactam Versus Ceftazidime-Avibactam in the Treatment of Hospitalized Adult Patients With Complicated Urinary Tract Infection or Acute Pyelonephritis Ertapenem-zidebactam, Ceftazidime-Avibactam, Ertapenam-Zidebactam - Complicated Urinary Tract Infections(cUTI), Acute Pyelonephritis | Phase 2 | Not yet recruiting | Wockhardt | 279 | 2026-09-30 | 2026-09-24 |
| A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination. Zidebactam-Cefepime, Metronidazole, FEP-ZID - PHA1A | Phase 1 | Completed | Wockhardt | 30 | 2025-01-21 | 2025-09-16 |
| Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) WCK 4282 (FEP-TAZ) 4 g, Meropenem, ciprofloxacin 500 mg Optional Oral Switch - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 3 | Unknown | Wockhardt | 1004 | 2024-01-01 | 2023-07-17 |
| Study of Cefepime-zidebactam (FEP-ZID) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) Cefepime-zidebactam (FEP-ZID), Meropenem - Complicated Urinary Tract Infection, Acute Pyelonephritis | Phase 3 | Completed | Wockhardt | 530 | 2022-08-28 | 2026-05-22 |
| Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin Nafithromycin, Placebo - Healthy | Phase 1 | Completed | Wockhardt | 10 | 2019-06-18 | 2019-10-02 |
| To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) FEP-TAZ 4 g, Placebo - Antibiotics Causing Adverse Effects in Therapeutic Use | Phase 1 | Completed | Wockhardt | 20 | 2018-03-23 | 2018-08-10 |
| Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion. zidebactam administered as a 1g (approximately 200 μCi) IV infusion over 1 hour - Healthy Subjects (HS) | Phase 1 | Completed | Wockhardt | 8 | 2017-12-13 | 2026-02-18 |
| Comparative Study of Levonadifloxacin (IV and Oral) With Linezolid (IV and Oral) in Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Oral Levonadifloxacin/Linezolid Tablet, Intravenous Levonadifloxacin/Linezolid Infusion - Acute Bacterial Skin and Skin Structure Infections | Phase 3 | Completed | Wockhardt | 501 | 2017-08-25 | 2020-06-29 |
| Plasma and Intrapulmonary Concentrations Study of WCK 5222 FEP-ZID - PHA1A | Phase 1 | Completed | Wockhardt | 36 | 2017-03-31 | 2018-08-14 |
| Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers WCK 5222, IV placebo matched to WCK 5222 / Moxifloxacin IV solution, Moxifloxacin 400-mg - QT/QTc Interval in Healthy Volunteers | Phase 1 | Completed | Wockhardt | 60 | 2017-02-09 | 2018-06-13 |
| Phase II Study of Oral Nafithromycin in CABP Nafithromycin 800 mg 3 days, Nafithromycin 800 mg 5 days, Moxifloxacin 400 mg - Community-Acquired Bacterial Pneumonia (CABP) | Phase 2 | Completed | Wockhardt | 231 | 2016-11-18 | 2019-12-20 |
| To Investigate The Pharmacokinetics Of Intravenous WCK 5222 (FEP-ZID) In Patients With Renal Impairment WCK 5222 - Renal Impairment | Phase 1 | Completed | Wockhardt | 48 | 2016-10-25 | 2018-08-02 |
| A Phase 1 Pharmacokinetic Study of Single-Ascending Doses of Intravenous Nafithromycin in Healthy Adult Subjects Nafithromycin, Placebo - Healthy Volunteers | Phase 1 | Completed | Wockhardt | 60 | 2016-04-25 | 2018-08-01 |
| A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment Cefepime and Tazobactam combination - Renal Impairment | Phase 1 | Completed | Wockhardt | 48 | 2016-03-01 | 2016-08-26 |
| MED Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous WCK 5222 (Zidebactam and Cefepime) in Healthy Volunteers Intravenous infusions of WCK 5222, Placebo - Serious Gram-negative Infections | Phase 1 | Completed | Wockhardt | 20 | 2016-03-01 | 2016-08-04 |
| MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults 3 g or 6 g Zidebactam, Placebo - Healthy Subjects | Phase 1 | Completed | Wockhardt | 21 | 2016-02-01 | 2025-09-30 |
| Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime WCK 5107 250 mg to 2000 mg, Cefepime 2000 mg, WCK 5107 1000/2000 mg with Cefepime 2000 mg combination - Healthy | Phase 1 | Completed | Wockhardt | 88 | 2015-08-01 | 2016-05-03 |
| Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects WCK 4873 - Healthy | Phase 1 | Completed | Wockhardt | 36 | 2015-04-01 | 2015-08-03 |
| Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment WCK 2349 - Hepatic Impairment | Phase 1 | Completed | Wockhardt | 48 | 2014-09-01 | 2015-10-29 |
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Diabetes Mellitus (5) · Diabetes Mellitus, Type 1 (3) · Renal Insufficiency (2)
nafithromycin (6) · cefepime-zidebactam (5) · Insulin (4) · Insulin Lispro (4) · levonadifloxacin (4) · Cefepime (3) · Moxifloxacin (3) · Insulin Glargine (2) · Meropenem (2) · avibactam, ceftazidime drug combination (2) · Ciprofloxacin (1) · Colistin (1) · Isophane Insulin, Human (1) · Linezolid (1) · Metronidazole (1)
United States (30) · India (5) · Bulgaria (2) · Lithuania (2) · Poland (2) · Bosnia and Herzegovina (1) · China (1) · Croatia (1) · Estonia (1) · France (1) · Georgia (1) · Greece (1) · Italy (1) · Mexico (1) · Moldova (1)
Ashima Bhatia, MD (2) · Carlos Sanabria, MD (2) · Ashima Bhatia, M.D. (1) · Ashima Bhatia, MD PDCR (1) · Dr Ashima Bhatia, M.D. (1) · Dr Ashima Bhatia, MD (1) · Dr. Elaine Watkins (1) · Dr. Marcus Hompesch (1) · Dr.Rasendrakumar Jha (1) · Heidi Guthrie (1) · Linda Morrow, M.D (1) · Manishkumar D Shah, PhD (1) · Marcus Hompesch, MD (1) · Mark H Gotfried, MD (1) · Rakesh Chugh, MD (1)
PMID 28696231, PMID 29263070, PMID 30397067, PMID 31332068, PMID 32738837, PMID 33332545