Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)

Phase 4

Completed

• Conditions: Antibiotic Resistant Infection; UTI - Lower Urinary Tract Infection
• Interventions: Drug: Ciprofloxacin

• Registration Number: NCT03366207
• Lead Sponsor: Iterum Therapeutics, International Limited

Brief Summary

This is a prospective, Phase 4, open label, multi-center study of the clinical and microbiologic efficacy of ciprofloxacin for the treatment of uncomplicated urinary tract infections in adult women.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-04
• Study First Submitted QC: 2017-12-04
• Study First Posted: 2017-12-08
• Study Start: 2017-12-15
• Primary Completion: 2018-07-31
• Study Completion: 2018-10-26
• Status Verified: 2019-07
• Results First Submitted: 2019-07-31
• Results First Submitted QC: 2019-07-31
• Results First Posted: 2019-08-21
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 250

Inclusion Criteria

1. Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI

2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria

3. A mid-stream urine specimen with:

   1. a dipstick analysis positive for nitrite AND
   2. a dipstick analysis positive for leukocyte esterase

4. Has given written informed consent to participate in the study.

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Exclusion Criteria

1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting
2. Receipt of prior effective antibacterial drug therapy for uUTI for the presenting illness unless the recovered pathogen demonstrates resistance to initial antibiotic and clinical symptoms persist
3. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI
4. Patients with ileal loops or urinary stoma
5. Patients with an indwelling urinary catheter in the previous 30 days
6. Patients with paraplegia
7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
8. Any history of trauma to the pelvis or urinary tract
9. Patient's urine culture results, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a potential fungal pathogen
10. Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin
11. Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant
12. Patient is known to have severe neutropenia
13. Patient is known to be pregnant
14. Patients with uncontrolled diabetes mellitus
15. Patients with a known history of myasthenia gravis
16. Patients who require concomitant administration of tizanidine
17. Patients with a history of allergy to quinolones
18. Patient is considered unlikely to survive the study period or has a rapidly progressive or terminal illness including septic shock which is associated with a high risk of mortality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin	Ciprofloxacin	Ciprofloxacin for the treatment of uncomplicated urinary tract infection

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Combined Clinical and Microbiologic Response	From start of treatment until assessment of cure, approximately 12 days	Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen

Secondary Outcome Measures

Name	Time	Method
Microbiologic Response	From start of treatment until assessment of cure, approximately 12 days	Microbiologic response is defined as demonstrating \<1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit

Trial Locations

Locations (1)

Restore Clinical Research; 🇺🇸 Cary, North Carolina, United States