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A multicenter, randomized, single-blind, controlled clinical study on biapenem injection in the treatment of bacterial lower respiratory tract and urinary tract infections

A multicenter, randomized, single-blind, controlled clinical study on biapenem injection in the treatment of bacterial lower respiratory tract and urinary tract infections

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001943
Enrollment
Unknown
Registered
2012-02-17
Start date
2009-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bacterial lower respiratory tract and urinary tract infections

Interventions

Biapenem group:biapenem versus meropenem

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inpatients and a few outpatients aged from 18 to 70 years old, regardless of their gender and ethnicity, who were diagnosed of either lower respiratory tract infections or UTIs (including acute episodes of chronic infections) caused by bacteria were eligible for the study. In additional to symptoms, signs and laboratory results, lower respiratory infections should be proven by radiography, and UTIs must be upper urinary tract infections or complicated urinary tract infections. Meanwhile, enrollment of patients with healthcare-associated infections was encouraged.

Exclusion criteria

Exclusion criteria: Patients must either not have had received antimicrobial therapy within 48 hours before study enrollment or may have had received ineffective antimicrobial therapy proven by clinical response and positive culture. Patients with any of the following conditions were excluded: history of hypersensitivity to ß-lactams; serum creatinine level above the upper limit of the normal range or creatinine clearance 1.5 times of the upper limit of the normal range; severe cardiac or haematological abnormalities; terminal malignancy; central nervous system illness or immunodeficiency; complex infections that needed combination therapy with other antimicrobial drugs; pregnant or lactating woman; psychiatric illness; or non-bacterial infections.

Design outcomes

Primary

MeasureTime frame
Clinical efficacy;

Secondary

MeasureTime frame
Bacteriological efficacy;

Countries

China

Contacts

Public ContactLv Xiaoju
lvxj3396@yahoo.com.cn+86 18980601315

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026