Clinical trial NCT03366207: Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI)
Official title: Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: UTI - Lower Urinary Tract Infection
Antibiotic Resistant Infection
Lead sponsor: Iterum Therapeutics, International Limited
Sponsor class: INDUSTRY
First posted: 2017-12-08
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label study of ciprofloxacin for uncomplicated urinary tract infection
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Number of Subjects With Combined Clinical and Microbiologic Response
timeFrame: From start of treatment until assessment of cure, approximately 12 days
Secondary outcomes:
measure: Microbiologic Response
timeFrame: From start of treatment until assessment of cure, approximately 12 days
Other outcomes:
Locations:
city: Cary
country: United States
facility: Restore Clinical Research
state: North Carolina
Study officials:
affiliation: Iterum Therapeutics
name: Steven Aronin, MD
role: PRINCIPAL_INVESTIGATOR
References: