Phase 4
N=250
Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
UTI - Lower Urinary Tract Infection · Antibiotic Resistant Infection
Bottom Line
View on ClinicalTrials.gov: NCT03366207 ↗Enrolled (actual)
250
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Number of Subjects With Combined Clinical and Microbiologic Response — 70 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ciprofloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Iterum Therapeutics, International Limited
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Combined Clinical and Microbiologic Response |
70 | — |
| SECONDARY Microbiologic Response |
96 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT03366207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.