Prospective observational study to evaluate appropriate dosage and efficacy of cephamycin and oxacephem for invasive UTI due to ESBL-E. coli

Prospective observational study to evaluate appropriate dose and efficacy of cephamycin and oxacephem for invasive UTI due to ESBL-E. coli - CMZ/FMOX for ESBL-E. coli UTI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000041639

Enrollment

Registered

2020-09-01

Start date

2019-12-06

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

invasive UTI

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Over 20 years old Patients with a fever of 37.5 or more, or any of the following: back pain, flank pain pain, or renal pain Confirmation of pyuria prior to initiation of antimicrobials by any of the following criteria 1) Urine sediment: >=5 WBCs/HPF 2) Non-centrifugation urine: >=10 WBCs/microL 3) Urine test paper method using non-centrifuged urine (based on the principle of measuring esterase activity): Positive ESBL-producing E. coli detected in urine (>= 104 CFU/mL) In cases where ESBL-producing E. coli is detected in blood only, no other source of infection other than the urinary tract is found. within 3 days of the submission of urine culture any of the study drugs must be started. The eligible drug must be cefmetazole (cephamycin), flomoxef (oxacephem), or carbapenem (meropenem). Empirical antimicrobial treatment with other agents prior to initiation is acceptable, but the patient must have been switched to one of the study drugs within 48 hours. Patients must have used the study drug for at least 4 consecutive days (including the day of initiation). Patients who have been switched to an effective oral antimicrobial agent after receiving the target drug will also be considered eligible patients.

Exclusion criteria

Exclusion criteria: Patients with a history of invasive urinary tract infection within 4 weeks prior to onset - Patients with concomitant use of antimicrobial agents (beta-lactams, aminoglycosides, fluoroquinolones, ST-fusions, colistin, tigecycline, minomycin, doxycycline, nitrofurantoin, and fosfomycin) that may be effective against ESBL-producing E. coli in addition to the study drug. - Persons with a history of hypersensitivity to cephem and carbapenem antibiotics - Dialysis patients (hemodialysis and peritoneal dialysis) - Other items that the principal investigator deems inappropriate for inclusion in the research

Design outcomes

Primary

Measure	Time frame
Bacteriological and clinical efficacy in the early stage of treatment with intravenous cephamycin/oxacephem or carbapenem (days 4 to 6 after initiation of treatment [start date = day 1])	—

Countries

Japan

Contacts

Public ContactKayoko Hayakawa

NCGM DCC

khayakawa@hosp.ncgm.go.jp03-3202-7181

Outcome results