Pyelonephritis Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized, Phase 3 Study to Compare the Safety and Efficacy of Intravenous CXA-201 and Intravenous Levofloxacin in Complicated Urinary Tract Infection, Including Pyelonephritis
This is a Phase 3, multicenter, prospective, randomized, double-blind, double dummy study of CXA 201 IV infusions (1500 mg q8h) versus levofloxacin IV infusions (750 mg qd) for the treatment of adults with a cUTI (including pyelonephritis).
Approximately 500 subjects will be enrolled into this study and randomized 1:1 to receive CXA-201 or comparator (levofloxacin) resulting in 250 subjects per treatment arm. Subject participation will require a minimum commitment of 35 days and a maximum of 42 days. Subjects will be hospitalized for the administration of all doses of IV study therapy. A test of cure visit will occur at 7 days after the last dose of study drug and a late follow-up evaluation or contact will occur a minimum of 28 days and a maximum of 35 days after the last dose of study drug. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03282006 -
Treating Pyelonephritis an Urosepsis With Pivmecillinam
|
Phase 4 | |
| Completed |
NCT02246361 -
Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication
|
Phase 4 | |
| Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
| Completed |
NCT03275623 -
Management of Sub-Clinical Bacteriuria in Pregnancy
|
Phase 4 | |
| Completed |
NCT00210886 -
A Comparison of the Effectiveness and Safety of Levofloxacin to That of Ciprofloxacin in Treating Complicated Urinary Tract Infection and Acute Pyelonephritis.
|
Phase 3 | |
| Completed |
NCT00528476 -
Risk Factors for Recurrent Urinary Tract Infection in Children
|
N/A | |
| Completed |
NCT03873701 -
Bedside Ultrasonography in Acute Patients With Suspected Kidney Involvement
|
||
| Completed |
NCT00382343 -
A Randomized Controlled Trial on Antibiotic Prophylaxis in Children With Vesico-Ureteral Reflux
|
Phase 4 | |
| Recruiting |
NCT03959163 -
The Validity of the Quick Renal MRI in Pediatric Kidney Disease
|
N/A | |
| Completed |
NCT01861353 -
Cranberry-lingonberry Juice Started During Acute Infection in Prevention of Urinary Tract Infections in Children
|
N/A | |
| Terminated |
NCT01628900 -
Prospective Study in the Emergency
|
Phase 2 | |
| Completed |
NCT01505634 -
Safety, Tolerability, and Efficacy of MK-7655 (Relebactam) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone for Treating Complicated Urinary Tract Infection (cUTI) (MK-7655-003)
|
Phase 2 | |
| Not yet recruiting |
NCT06128213 -
NRX-101 for Complicated Urinary Tract Infection (UTI) Including Pyelonephritis
|
Phase 2 | |
| Completed |
NCT00210990 -
Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis
|
Phase 3 | |
| Completed |
NCT00258089 -
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Complicated Urinary Tract Infections
|
Phase 3 | |
| Completed |
NCT01641029 -
Community-Associated Uropathogen Antimicrobial Resistance Among Emergency Department Patients With Acute Pyelonephritis
|
N/A | |
| Terminated |
NCT00724256 -
Short-term Antibiotic Therapy for Pyelonephritis in Childhood
|
Phase 3 | |
| Completed |
NCT00136656 -
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
|
Phase 4 | |
| Completed |
NCT04594161 -
Effectiveness of Drainage by PCN vs. JJ in Patients With Symptoms of Obstructive Kidney Disease Caused by Urolithiasis
|
N/A | |
| Completed |
NCT02080182 -
Effect of Acetylcysteine in Pediatric Acute Pyelonephritis.
|
Phase 2 |