A Phase 2, Randomized, Double-blind, Positive-control, Multicenter, Prospective Study to Assess Efficacy and Safety of Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Sihuan Pharmaceutical Holdings Group Ltd.1 site in 1 country112 target enrollmentDecember 13, 2018

ConditionsComplicated Urinary Tract Infection Including Acute Pyelonephritis

InterventionsBenapenem Ertapenem

DrugsBenapenem Ertapenem

Overview

Phase: Phase 2
Intervention: Benapenem
Conditions: Complicated Urinary Tract Infection Including Acute Pyelonephritis
Sponsor: Sihuan Pharmaceutical Holdings Group Ltd.
Enrollment: 112
Locations: 1
Primary Endpoint: Percentage of patients with clinical cure at test-of-cure (TOC) visit
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

Registry

clinicaltrials.gov

Start Date

December 13, 2018

End Date

May 8, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sihuan Pharmaceutical Holdings Group Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged 18-75 years
•Have a diagnosis of cUTI or AP as defined below:
•cUTI definition:
•At least Two of the following signs and symptoms:
•Chills, rigors, or fever; fever must be observed and documented by a health care provider (tympanic temperature ≥37.3°C)
•Flank pain or Lower abdominal pain
•Dysuria, urgency to void, or increased urinary frequency
•Nausea or vomiting
•Costovertebral angle tenderness or renal percussive pain on physical examination.
•Blood leukocytes above upper limit of normal value

Exclusion Criteria

•Receipt of potentially effective antibiotic therapy more than 24h within 72 h prior to randomization
•Anticipated concomitant use of other systemic antibiotic drugs during the study period
•Anticipated continnue to preventive anti-infectious therapy after cUTI patients completed investigational drug treatment
•Presence of any known or suspected disease or condition as following:
•Uncomplicated urinary tract infection (uUTI)
•Fungal Urinary tract infection
•Perinephric or renal corticomedullary abscess
•Polycystic kidney disease
•Urinary tuberculosis
•Obstructive uropathy(e.g.congenital malformation) unable to remove during treatment.

Arms & Interventions

test drug arm

Benapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.

Intervention: Benapenem

active control arm

Ertapenem for IV injection administered as a 1-gram IV infusion over 30 min once daily for 7 to 14 days.

Intervention: Ertapenem

Outcomes

Primary Outcomes

Percentage of patients with clinical cure at test-of-cure (TOC) visit

Time Frame: Day 7 +/- 1 days after the end of treatment

Clinical cure is defined as complete resolution of signs,symptoms and related laboratory tests of cUTI or AP that were present at baseline and no new symptoms, such that no further antimicrobial therapy is warranted.