Bacterial Infections Clinical Trial
Official title:
A Phase 1, Open-label, Single-dose Study to Determine the Safety and Pharmacokinetics of ORAvance (Ceftibuten/Xeruborbactam Oral Prodrug [QPX7831]) in Participants With Renal Impairment
A Phase 1, open-label, single-dose study to determine the safety and pharmacokinetics of ORAvance (ceftibuten/xeruborbactam oral prodrug [QPX7831]) in participants with renal impairment
Qpex Biopharma, Inc. is developing an oral dosage form that delivers Xeruborbactam, a new boron-based beta-lactamase inhibitor with activity against both serine and metallo-beta-lactamases, for oral treatment in combination with a beta-lactam antibiotic. Ceftibuten is a cephalosporin antibiotic approved in the US for acute exacerbations of chronic bronchitis, acute bacterial otitis media and pharyngitis/ tonsillitis. This is a Phase 1 open-label, single-dose study to assess the safety, tolerability, and PK, of ceftibuten and xeruborbactam oral prodrug given in combination to participants with varying degrees of renal impairment as compared to participants with normal renal function. Objectives: The objectives of the study are: 1. To assess the PK of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment. 2. To evaluate the safety and tolerability of ceftibuten and xeruborbactam oral prodrug given in combination in participants with varying degrees of renal impairment. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03726216 -
Xydalba Utilization Registry in France
|
||
| Completed |
NCT03605498 -
OR PathTrac (Tracking Intra-operative Bacterial Transmission)
|
||
| Withdrawn |
NCT05269121 -
Bacteriophage Therapy in First Time Chronic Prosthetic Joint Infections
|
Phase 1/Phase 2 | |
| Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
| Recruiting |
NCT02074865 -
Children's Antibiotic Resistant Infections in Low Income Countries
|
N/A | |
| Completed |
NCT01932034 -
Prospective Study to Optimize Vancomycin Dosing in Children and Adults Using Computer Software
|
N/A | |
| Completed |
NCT01689207 -
To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)
|
Phase 1 | |
| Completed |
NCT01412801 -
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
|
Phase 2 | |
| Not yet recruiting |
NCT01159470 -
The Rate of C-reactive Protein (CRP) Increase as a Marker for Bacterial Infections in Children
|
N/A | |
| Completed |
NCT00983255 -
Ascending Dose Pharmacokinetic (PK) and Absolute Bioavailability (BA)
|
Phase 1 | |
| Completed |
NCT00799591 -
French Study In ICU Patients Treated With Tigecycline
|
N/A | |
| Completed |
NCT00678106 -
Study Of Dalbavancin Drug Levels Achieved In Hospitalized Adolescents Who Are Receiving Antibiotic Therapy For Bacterial Infections
|
Phase 1 | |
| Completed |
NCT00478855 -
Tazocin Intervention Study
|
Phase 4 | |
| Completed |
NCT01074775 -
Human Innate Immune Responses To Mycobacterial Aerodigestive Tract Infection
|
N/A | |
| Terminated |
NCT00431028 -
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT03634904 -
Serum Ceftazidime Concentrations in Hemodialysis Patients
|
N/A | |
| Recruiting |
NCT05684705 -
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
|
Phase 1 | |
| Recruiting |
NCT03858387 -
PK/PD and Clinial Outcomes of Beta-lactams in ICU Patients
|
||
| Enrolling by invitation |
NCT04764058 -
Efficacy and Safety of Colistin Based Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06319235 -
Clinical Trial to Demonstrate the Safety and Efficacy of DUOFAG®
|
Phase 1/Phase 2 |