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

Study Overview
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Brief Summary
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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.

Official Title
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Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.

Conditions
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UTI - Lower Urinary Tract Infection, Antibiotic Resistant Infection

Intervention / Treatment
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* Drug: Ciprofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients ≥18 years of age with more than 24 hours of urinary symptoms attributable to a UTI Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain, gross hematuria A mid-stream urine specimen with: a dipstick analysis positive for nitrite AND a dipstick analysis positive for leukocyte esterase Has given written informed consent to participate in the study. Exclusion Criteria: Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature > 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea and/or vomiting 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 Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI Patients with ileal loops or urinary stoma Patients with an indwelling urinary catheter in the previous 30 days Patients with paraplegia Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux) Any history of trauma to the pelvis or urinary tract 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 Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is known to have severe neutropenia Patient is known to be pregnant Patients with uncontrolled diabetes mellitus Patients with a known history of myasthenia gravis Patients who require concomitant administration of tizanidine Patients with a history of allergy to quinolones 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label study of ciprofloxacin for uncomplicated urinary tract infection
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprofloxacin<br>Ciprofloxacin for the treatment of uncomplicated urinary tract infection | Drug: Ciprofloxacin<br>* Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.<br>* Other names: Cipro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Combined Clinical and Microbiologic Response | 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 | From start of treatment until assessment of cure, approximately 12 days | 

Secondary Outcome Measures

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