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Phase 4 N=250 Treatment

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

UTI - Lower Urinary Tract Infection · Antibiotic Resistant Infection

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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