Clinical Trials Logo

Clinical Trial Summary

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.


Clinical Trial Description

This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03445195
Study type Interventional
Source Entasis Therapeutics
Contact
Status Completed
Phase Phase 2
Start date January 17, 2018
Completion date May 17, 2018

See also
  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
Recruiting 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 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