Comparative study of the safety and efficacy of levofloxacin and ciprofloxacin in the treatment of community-acquired, bacterial urinary tract infection among patients with chronic kidney disease

Phase 3

• Conditions: Urinary tract infection, Chronic kidney disease; Kidney Disease

• Registration Number: PACTR202401622249032
• Lead Sponsor: Dhikrullah Adebayo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-12-05
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1.Age 18years and above.
2.Known CKD patients
3.Symptoms compatible with a diagnosis of UTI plus positive dipstick test for pyuria
4.Informed consent to participate in the study.

Exclusion Criteria

1.Patients with any rapidly progressive or terminal disease
2.Individuals with prior renal transplantation.
3.Co-existence of other infections in addition to urinary tract infection
4.Exposure to any antimicrobial prior to presentation
5.Known previous reaction to quinolones.
6.Hospital acquired UTI
7.Catheter associated UTI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Efficacy as determined by clinical resolution, clearance of signs and symptoms <br>2.Tolerability of drug as determined by Treatment Emergent Symptoms and Signs (TESS) <br>

Secondary Outcome Measures

Name	Time	Method
1.Duration of hospital stay and/or hospitalization and/or re-hospitalization<br>2.Rate of re-occurrence of UTI and/or any bacterial infections during the subsequent 3 months of follow up.<br>3.All-cause mortality among participants <br>