10 completed, 1 not yet recruiting, 1 recruiting. 7 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 7 |
| Phase 2 | 5 | Completed 3, Not yet recruiting 1, Recruiting 1 |
Follow avibactam: new trials by email Literature Review of avibactam trials Research Report on avibactam
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, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex BV100 with 50 mg polymyxin B plus ceftazidime/avibactam, BV100 with 50 mg polymyxin B plus cefiderocol, Best Available Therapy (BAT) - Ventilator Associated Bacterial Pneumonia (VABP), Hospital Acquired Bacterial Pneumonia (HABP) | Phase 2 | Not yet recruiting | BioVersys AG | 120 | 2026-07-01 | 2026-02-24 |
| Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections ATM-AVI, BAT - Gram-negative Bacterial Infections | Phase 2 | Recruiting | Pfizer | 48 | 2023-04-18 | 2026-07-01 |
| Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers Group 1:YK-1169, Group 2:YK-1169/Placebo Injection, Group 3:YK-1169/Placebo - Pharmacokinetics | Phase 1 | Completed | Nanjing Yoko Biomedical Co., Ltd. | 66 | 2021-12-20 | 2022-10-20 |
| To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) Avibactam (AVI), Aztreonam (ATM), combination of Aztreonam - Avibactam (ATM-AVI) - Complicated Infection, Bacterial Infections | Phase 1 | Completed | Pfizer | 222 | 2012-09-01 | 2017-09-06 |
| Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance Ceftaroline fosamil/Avibactam (CXL) - Augmented Renal Clearance (ARC), Systemic Inflammatory Response Syndrome (SIRS) | Phase 1 | Completed | Forest Laboratories | 12 | 2012-05-01 | 2017-04-07 |
| A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately CAZ104, Avibactam, Ceftazidime - Healthy | Phase 1 | Completed | Pfizer | 43 | 2011-09-01 | 2017-09-01 |
| Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma CAZ104 - Healthy | Phase 1 | Completed | Pfizer | 45 | 2011-08-01 | 2017-09-01 |
| A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers NXL104, Ceftaroline, Placebo Infusion - Healthy Male Volunteers | Phase 1 | Completed | Pfizer | 54 | 2011-02-01 | 2017-09-01 |
| A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects NXL104, CAZ104, Placebo - Healthy Male and Female Japanese Volunteers | Phase 1 | Completed | Pfizer | 15 | 2011-02-01 | 2017-09-01 |
| Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections Ceftaroline fosamil and NXL104 (q8h), Ceftaroline fosamil and NXL104 (q12h), Doripenem - Urinary Tract Infections | Phase 2 | Completed | Forest Laboratories | 217 | 2010-12-01 | 2014-02-03 |
| Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections ceftazidime/NXL104 + metronidazole, meropenem - Complicated Intra-abdominal Infections | Phase 2 | Completed | Pfizer | 204 | 2009-03-31 | 2018-07-03 |
| Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections NXL104/ceftazidime, Imipenem/Cilastatin - Complicated Urinary Tract Infection | Phase 2 | Completed | Pfizer | 137 | 2008-11-01 | 2018-05-25 |
Urinary Tract Infections (2) · Bacterial Infections (1) · Central Nervous System Infections (1) · Cerebral Ventriculitis (1) · Gram-Negative Bacterial Infections (1) · Intraabdominal Infections (1) · Meningitis, Bacterial (1) · Systemic Inflammatory Response Syndrome (1)
Pfizer (8) · Forest Laboratories (2) · BioVersys AG (1) · Nanjing Yoko Biomedical Co., Ltd. (1)
United States (7) · Lebanon (3) · United Kingdom (3) · Bulgaria (2) · China (2) · India (2) · Poland (2) · Russia (2) · Turkey (Türkiye) (2) · Australia (1) · France (1) · Germany (1) · Greece (1) · Hungary (1) · Jordan (1)
Paul Newell, MD (4) · Mirjana Kujacic, MD (2) · Carole A Sable, MD (1) · David Mathews, MD (1) · Frans van den Berg, MD (1) · Leonard Siew, MBCHB (1) · Leonard Siew, MBCHB, MRCP(UK) (1) · Mark Yen, MD (1)
PMID 30221827, PMID 23145859, PMID 24150927, PMID 30061279, PMID 38252170