Status:
COMPLETED
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
Lead Sponsor:
Iterum Therapeutics, International Limited
Conditions:
UTI - Lower Urinary Tract Infection
Antibiotic Resistant Infection
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2018
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT03366207
Start Date
December 15 2017
End Date
October 26 2018
Last Update
September 6 2019
Active Locations (1)
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1
Restore Clinical Research
Cary, North Carolina, United States, 27518