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Efficacy, safety and pharmacokinetics of latamoxef in ESBL-producing Enterobacteriaceae urinary tract infection patients: a prospective, multi-centered, open-label, randomized controlled trial

Efficacy, safety and pharmacokinetics of latamoxef in ESBL-producing Enterobacteriaceae urinary tract infection patients: a prospective, multi-centered, open-label, randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034023
Enrollment
Unknown
Registered
2020-06-21
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-22

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

Conditions

ESBL-producing Enterobacteriaceae urinary tract infection

Interventions

Latamoxef group:treated with latamoxef 1g every 8hours
Piperacillin /tazobactam group:treated with Piperacillin/tazobactam 4.5h every 8 hours
PK group:treated with latamoxef 1g every 9 hours with a first dose of 1g or 2g

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patient with a diagnosis or a suspected diagnosis of Enterobacteriaceae urinary tract infection, and suitable to be treated with latamoxef. 2. Patient with ESBL high risk factors, such as history of repeated use of antibiotics, indwelling catheters, urinary tract or biliary tract calculus, history of ESBL-producing bacteria infection, hospitalization, ICU stay, old age, diabetic, immunodeficiency, mechanical ventilation. 3. Treatment length of systemic gram-negative bacteria active antibiotics less than 24 hours prior 72 hours of treatment, unless treatment failure can be identified. 4. Patient attend this research voluntary and sign the informed consent form. 5. Aged more than 18 years. for patients attending PK group, additional inclusion criteria is needed: (1) patient with an endogenous creatinine clearance rate in the range of 60-120 mL/min (calculated by CG equation). (2) patient with a BMI in the range of 18.5-26 kg/m2. (3) suitable for continuously sampling.

Exclusion criteria

Exclusion criteria: 1. Patients with prostatitis or suspected prostatitis, 2. History of kidney transplant, 3. Injury history of urinary tract or pelvis in 3 months, 4. Pregnant, or lactation period, 5. Critic ill patient, such as sepsis or MODS, 6. Mixed infection patients who needs combined antibiotics, 7. End stage of any disease, 8. Allergy history of latamoxef or piperacillin, 9. Attend other trials in 30 days.

Design outcomes

Primary

MeasureTime frame
efficacy;PK parameters;

Countries

China

Contacts

Public ContactYu Yunsong

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

yvys119@163.com+86 0571-88606660

Outcome results

None listed

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