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

NCT04505683 | Completed Phase 2

• 1 other identifier: 5081-II-2001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complicated Urinary Tract Infection Including Acute Pyelonephritis

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

test drug arm

EXPERIMENTAL

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

Drug: Benapenem

active control arm

ACTIVE COMPARATOR

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

Drug: Ertapenem

Interventions

Benapenem DRUG

Benapenem for IV injection administered as a 1-gram IV infusion

test drug arm

Ertapenem DRUG

Ertapenem for IV injection administered as a 1-gram IV infusion

active control arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• And at least One of the following risk factors for cUTI:
• Implanted urinary tract instrumentation (e.g., nephrostomy tube, ureteric stents), ongoing intermittent bladder catheterization, or presence of an indwelling bladder catheter (Note: bladder catheters prior to Screening should be expected to remove during study period
• post-void residual urine volume of ≥ 100 mL;
• Obstructive uropathy (e.g. bladder outlet obstruction, nephrolithiasis, prostatic hyperplasia) that is expected to be removed during study drug therapy;
• Perioperative urinary tract infection.

You may not qualify if:

• 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.
• Ideal loop surgery or vesicoureteral reflux
• Permannent bladder catheterization or long term indwelling nephrostomy tube
• Previous or planned renal transplantation
• Patients undergoing dialysis"
• Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis

Sponsors & Collaborators

• Sihuan Pharmaceutical Holdings Group Ltd.: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Interventions

benapenem; Ertapenem

Intervention Hierarchy (Ancestors)

Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 10, 2020
• Study Start: December 13, 2018
• Primary Completion: May 8, 2020
• Study Completion: May 8, 2020
• Last Updated: August 10, 2020

Record last verified: 2020-08

Locations

CN (1)