ceftibuten/avibactam prodrug (PF-07612577) / Pfizer - LARVOL DELTA

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 (clinicaltrials.gov) - P1 | N=13 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Trial completion

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 (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting | N=16 ➔ 9

Enrollment change • Enrollment closed

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 (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: Pfizer

New P1 trial

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed

Trial completion

Determination of MIC Quality Control Ranges for Ceftibuten-Avibactam (Fixed 4 μg/mL), a Novel β-Lactam/β-Lactamase Inhibitor Combination. (PubMed, J Clin Microbiol) - "Ceftibuten/ARX-1796 (avibactam prodrug) is a novel oral antibacterial combination in early clinical development for the treatment of complicated urinary tract infections (cUTI) including pyelonephritis. Ceftibuten-avibactam broth microdilution QC ranges were approved for Escherichia coli ATCC 25922 (0.016/4 to 0.12/4 μg/mL), E. coli NCTC 13353 (0.03/4 to 0.12/4 μg/mL), Klebsiella pneumoniae ATCC 700603 (0.06/4 to 0.25/4 μg/mL), K. pneumoniae ATCC BAA-1705 (0.03/4 to 0.25/4 μg/mL), and K. pneumoniae ATCC BAA-2814 (0.12/4 to 0.5/4 μg/mL) by the CLSI Subcommittee on Antimicrobial Susceptibility Testing in January 2022. Approved ceftibuten-avibactam QC ranges will support future clinical development, device manufacturers, and routine patient care."

Journal • Infectious Disease • Nephrology • Pneumonia

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: Pfizer | Trial completion date: Mar 2023 ➔ Aug 2023 | Trial primary completion date: Mar 2023 ➔ Aug 2023

Trial completion date • Trial primary completion date

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Pfizer | Not yet recruiting ➔ Recruiting

Enrollment open

A Study to Learn About the Study Medicine Called CTB+AVP in Healthy Adult People. (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: Pfizer

New P1 trial

Oral Antibiotics in Clinical Development for Community-Acquired Urinary Tract Infections. (PubMed, Infect Dis Ther) - "Oral carbapenems (tebipenem and sulopenem) and oral cephalosporin/β-lactamase inhibitor combinations are in various stages of clinical development for the treatment of uncomplicated and complicated UTI...The β-lactamase inhibitors ETX0282, VNRX7145, ARX1796, and QPX7728 are combined with cefpodoxime proxetil or ceftibuten that achieve favorable exposures in urine compared to other uropathogen-active oral cephalosporins...Other novel combinations, namely cefpodoxime/ETX0282, ceftibuten/VNRX-7145, and ceftibuten/ARX1796, have also demonstrated excellent activity against Klebsiella pneumoniae carbapanemase (KPC) and OXA-48-like producers. All these agents, upon their arrival for commercial use, would strengthen the outpatient therapy."

Clinical • Journal • Infectious Disease • Nephrology • Pneumonia