Acute Pyelonephritis Clinical Trial
Official title:
Expanded Access for the Use of Sulopenem Etzadroxil/Probenecid for the Treatment of Patients With Complicated Urinary Tract Infection Due to Quinolone-nonsusceptible Uropathogens
Sulopenem etzadroxil/probenecid is available to clinicians through an Expanded Access Program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. The investigational product may be requested by sending an email to the Sponsor (EAProgram@iterumtx.com), as listed on the Reagan Udall EAP Navigator website (https://navigator.reaganudall.org/company-directory/i).
This Expanded Access Program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. The recommended dose of sulopenem etzadroxil/probenecid 500 mg/ 500 mg is one bilayer tablet orally twice daily, taken with food whenever possible. No dose adjustment is required for patients with renal impairment. Duration of therapy will be at the discretion of the prescribing clinician, depending on the type of infection being treated and the response to therapy, and is expected to be less than ten days total. ;
| 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 |
NCT02166476 -
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
|
Phase 3 | |
| 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 |
NCT04686318 -
Accuracy of Infection Biomarkers in the Investigation of Patients With Suspected Acute Pyelonephritis
|
||
| Completed |
NCT04667195 -
Clinical Characteristics of Acutely Hospitalized Adults With 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 |