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Study on the efficacy and safety of cephalexin for acute uncomplicated cystitis

Study on the efficacy and safety of cephalexin for acute uncomplicated cystitis - Studies on cephalexin for acute uncomplicated cystitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000049903
Enrollment
300
Registered
2022-12-26
Start date
2023-02-01
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

acute uncomplicated cystitis

Interventions

Cephalexin continuous formulation 500 mg (potency) twice daily for 7 days.

Sponsors

Sapporo Medical University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients with subjective symptoms of urinary pain, frequency, urinary urgency, and lower abdominal pain. However, patients with no symptoms of cystitis within 4 weeks prior to the current onset. Pyuria Patients whose pyuria prior to initiation of medication meets any of the following criteria Urine occult blood test by non-centrifugal urine 10 WBCs/hpf or greater Urine detector method with non-centrifuged urine positive Urine sediment sample positive 5 WBCs/hpf or greater

Exclusion criteria

Exclusion criteria: 1) Patients who received other antimicrobial agents prior to the start of study drug and whose symptoms are already improving. 2) Patients who have received a cephalosporin antibiotic within 1 week prior to the start of study drug administration 3) Patients with severe infections that are not expected to respond to oral therapy 4) Patients with serious underlying diseases or complications that make it difficult to evaluate the efficacy and safety of the study drug 5) Patients with a history of allergy to cephalosporins 6) Patients with severe cardiac or hepatic dysfunction 7) Patients with moderate or severe renal dysfunction (serum creatinine level should be 2 mg/dL or higher) 8) Patients with epilepsy or other convulsive disorders or a history of such disorders 9) Pregnant women, women who may be pregnant, and lactating women 10) Other patients deemed inappropriate by the attending physician

Design outcomes

Primary

MeasureTime frame
Primary efficacy from the end of the medication to 10 days after the end of the medication

Secondary

MeasureTime frame
Safety

Countries

Japan

Contacts

Public ContactMitsuru yasuda

Sapporo Medical University School of Medicine Department of Infection Control & Laboratory Medicine

yasuda7jpe@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026