CompletedPhase 2/3

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

China112 participantsStarted 2018-12-13

Plain-language summary

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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:
✕. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
✕. Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis
✕. Confirmed or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia)
✕. Trauma to the pelvis or urinary tract within 7days before enrollment

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

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

NCT IDNCT04505683

SponsorSihuan Pharmaceutical Holdings Group Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-08

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. 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:
✕. Confirmed or suspected acute or chronic bacterial prostatitis, orchitis, or epididymitis
✕. Confirmed or suspected sexually transmitted disease,e.g. gonorrhea and syphilis
✕. Confirmed or suspected non-renal source of infection (e.g., infective endocarditis, osteomyelitis, meningitis, pneumonia)
✕. Trauma to the pelvis or urinary tract within 7days before enrollment