Acute Pyelonephritis Clinical Trial
Official title:
Phase III, Randomized, Double-Blind, Study Evaluating Efficacy/Safety/Tolerability of Meropenem-Vaborbactam Compared to Piperacillin/Tazobactam in Adult Patients With Complicated Urinary Tract Infections, Including Acute Pyelonephritis
Meropenem-vaborbactam is being compared to piperacillin-tazobactam in the treatment of adults with complicated urinary tract infection (cUTI) or acute pyelonephritis (AP).
In the current era of increased resistance to extended spectrum cephalosporins, carbapenem
antimicrobial agents are frequently the antibiotics of "last defense" for the most resistant
pathogens in serious infections, including those found in cUTIs. The recent dissemination of
serine carbapenemases in Enterobacteriaceae in many hospitals worldwide now poses a
considerable threat to the carbapenems and other members of the beta-lactam class of
antimicrobial agents.
Rempex is developing meropenem-vaborbactam administered as a fixed combination by intravenous
infusion to treat serious Gram-negative infections such as cUTIs, including those infections
caused by bacteria resistant to currently available carbapenems.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05905055 -
P3 Study to Assess Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy for Adults With Infection Due to Carbapenem Resistant Enterobacterales
|
Phase 3 | |
| Not yet recruiting |
NCT05060419 -
Meropenem-FL058 Phase 2 Study in the Treatment of Complicated Urinary Tract Infections
|
Phase 2 | |
| Recruiting |
NCT02537847 -
Sitafloxacin and Ertapenem Treatment for Acute Pyelonephritis Caused by Escherichia Coli
|
Phase 2 | |
| Completed |
NCT03757234 -
IV or IV/PO Omadacycline vs. IV/PO Levofloxacin for the Treatment of Acute Pyelonephritis
|
Phase 2 | |
| Completed |
NCT06141395 -
NGS-Based Assay of Blood Samples of Sepsis Patients for Rapid Bacterial Identification
|
||
| Recruiting |
NCT05887908 -
Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis
|
Phase 3 | |
| Completed |
NCT02420366 -
Study of Cases of Serious Infections Due to Carbapenem-Resistant Enterobacteriaceae
|
||
| Recruiting |
NCT04654507 -
Efficacy of Corticosteroids in Reducing Renal Scarring in Acute Pyelonephritis in Children
|
Phase 3 | |
| Completed |
NCT04667195 -
Clinical Characteristics of Acutely Hospitalized Adults With Acute Pyelonephritis
|
||
| Completed |
NCT04686318 -
Accuracy of Infection Biomarkers in the Investigation of Patients With Suspected Acute Pyelonephritis
|
||
| Completed |
NCT03788967 -
Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) Compared to Intravenous Ertapenem in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
|
Phase 3 | |
| Recruiting |
NCT05674032 -
Bacterial Metallophores in the Diagnosis of Acute Pyelonephritis
|
||
| Completed |
NCT02168946 -
Efficacy, Safety, Tolerability of Vabomere Compared to Best Available Therapy in Treating Serious Infections in Adults
|
Phase 3 | |
| Completed |
NCT01096849 -
A Study of Plazomicin Compared With Levofloxacin for the Treatment of Complicated Urinary Tract Infection (cUTI) and Acute Pyelonephritis (AP)
|
Phase 2 | |
| Not yet recruiting |
NCT03630081 -
Study of Cefepime-tazobactam (FEP-TAZ) in Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
|
Phase 3 | |
| Completed |
NCT03445195 -
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
|
Phase 2 | |
| Completed |
NCT02486627 -
A Study of Plazomicin Compared With Meropenem for the Treatment of Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis (AP)
|
Phase 3 | |
| Completed |
NCT03477422 -
CSE-1034 (Ceftriaxone+ Sulbactam+ EDTA) Compared to Meropenem in Complicated Urinary Tract Infections (cUTIs) Caused by ESBL Producing Gram Negative Bacteria
|
Phase 3 | |
| Recruiting |
NCT06059846 -
A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
|
Phase 3 | |
| Completed |
NCT01928433 -
Finafloxacin for the Treatment of cUTI and/or Acute Pyelonephritis
|
Phase 2 |