A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF CARBAVANCE (MEROPENEM/RPX7009) COMPARED TO PIPERACILLIN/TAZOBACTAM IN THE TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING ACUTE PYELONEPHRITIS, IN ADULTS

Not Applicable

• Conditions: -N10 Acute tubulo-interstitial nephritis-N390 Urinary tract infection, site not specified; Urinary tract infection, site not specified; N390

• Registration Number: PER-002-15
• Lead Sponsor: REMPEX PHARMACEUTICALS Inc. subsidiaria de propiedad total de The Medicines Company,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1.A signed informed consent form, the ability to understand the study conduct and tasks that are required for study participation, and a willingness to cooperate with all tasks, tests, and examinations as required by the protocol.
2.Male or female 18 years of age.
3.Weight 150 kg.
4.Expectation, in the judgment of the Investigator, that the subject’s cUTI or AP requires initial treatment with at least 5 days of IV antibiotics.
5.Documented or suspected cUTI or AP as defined in the chart
Expectation, in the judgment of the Investigator, that any indwelling urinary catheter or instrumentation (including nephrostomy tubes and/or indwelling stents) will be removed or replaced (if removal is not clinically acceptable) before or as soon as possible, but not longer than 12 hours, after randomization.
7.Expectation, in the judgment of the Investigator, that the subject will survive with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study.
8.Women of childbearing potential must have a negative pregnancy test before randomization and be willing to use a highly effective method of contraception between randomization and for 7 days after the completion of the study.
9.Willingness to comply with all the study procedures, whether in the hospital or after discharge, for the duration of the study.

Exclusion Criteria

For additional exclusion criteria please refer to the protocol.
1.Presence of any of the following conditions:
a.Perinephric abscess;
b.Renal corticomedullary abscess;
c.Uncomplicated UTI;
d.Polycystic kidney disease;
e.Chronic vesicoureteral reflux;
f.Previous or planned renal transplantation;
g.Subjects receiving hemodialysis;
h.Previous or planned cystectomy or ileal loop surgery; or
i.Known candiduria.
2.Presence of acute bacterial prostatitis, orchitis, epididymitis, or chronic bacterial prostatitis as determined by history and/or physical examination.
3.Gross hematuria requiring intervention other than administration of study drug.
4.Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy).
5.Renal function at screening as estimated by creatinine clearance
<30 mL/min using the Cockcroft-Gault formula.
6.Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization.
7.Any of the following signs of severe sepsis

Study & Design

• Study Type: Interventional
• Study Design: Not specified