8 completed, 2 terminated, 1 recruiting. 9 Phase 1, 1 Early Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Recruiting 1 |
| Early Phase 1 | 1 | Terminated 1 |
| Phase 3 | 1 | Terminated 1 |
Follow Ceftibuten: new trials by email Literature Review of Ceftibuten trials Research Report on Ceftibuten
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 PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil - Healthy Volunteer, Pharmacokinetics | Phase 1 | Recruiting | Basilea Pharmaceutica | 96 | 2025-01-07 | 2026-11-05 |
| PK & Safety Study of Xeruborbactam Oral Prodrug Combined With Ceftibuten in Participants With Renal Impairment Xeruborbactam Oral Prodrug, Ceftibuten - Bacterial Infections | Phase 1 | Completed | Qpex Biopharma, Inc. | 32 | 2024-11-10 | 2025-05-14 |
| Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adults (18-55 Years) ledaborbactam etzadroxil, ceftibuten - Pharmacokinetics, Healthy Volunteers | Phase 1 | Completed | Basilea Pharmaceutica | 34 | 2024-11-04 | 2026-08-24 |
| To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults Ceftibuten, Avibactam prodrug, CTB-AVP in Tablet - Healthy | Phase 1 | Completed | Pfizer | 13 | 2024-07-29 | 2025-05-21 |
| P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants Xeruborbactam Oral Prodrug, Ceftibuten, Xeruborbactam Oral Prodrug Placebo - Bacterial Infections | Phase 1 | Completed | Qpex Biopharma, Inc. | 53 | 2024-01-30 | 2025-12-12 |
| Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function VNRX-7145, Ceftibuten - Pharmacokinetics | Phase 1 | Completed | Basilea Pharmaceutica | 32 | 2022-10-12 | 2025-12-08 |
| A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. Placebo, PF-07612577, PF-06264006 - Healthy | Phase 1 | Completed | Pfizer | 42 | 2022-10-07 | 2024-10-10 |
| Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants VNRX-7145, Ceftibuten - Pharmacokinetics | Phase 1 | Completed | Basilea Pharmaceutica | 24 | 2022-09-13 | 2025-12-08 |
| VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers VNRX-7145, VNRX-5024 (ceftibuten), Placebo - Healthy Subjects | Phase 1 | Completed | Basilea Pharmaceutica | 53 | 2021-06-08 | 2025-12-08 |
| Patients Response to Early Switch To Oral:Osteomyelitis Study oral antibiotics, intravenous antibiotics - Osteomyelitis | Early Phase 1 | Terminated | Julio Ramirez | 11 | 2014-03-06 | 2021-04-06 |
| Short-term Antibiotic Therapy for Pyelonephritis in Childhood ceftibuten - Pyelonephritis | Phase 3 | Terminated | IRCCS Burlo Garofolo | 36 | 2006-07-01 | 2012-02-17 |
Bacterial Infections (2) · Osteomyelitis (1) · Pyelonephritis (1) · Urinary Tract Infections (1)
Basilea Pharmaceutica (5) · Pfizer (2) · Qpex Biopharma, Inc. (2) · IRCCS Burlo Garofolo (1) · Julio Ramirez (1)
United States (6) · Belgium (2) · Australia (1) · Italy (1) · Netherlands (1)
Kamal Hamed, MD (4) · Jeff Loutit, MBChB (2) · David Seligson, MD (1) · Julio Ramirez, MD (1) · Kamal Hamed, MD, MPH (1) · Marzia Lazzerini, MD DTMH (1)
PMID 42678337, PMID 15276398, PMID 15840453, PMID 19588358, PMID 22530208, PMID 40762486, PMID 42008649, PMID 42803753, PMID 4902833, PMID 8948280
2023 (1), 272201600029C-P00007-9999-2 (1), 272201600029C-P00017-9999-1 (1), 272201600029C-P00026-9999-1 (1)