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

NCT ID: NCT03366207

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-15
• Study Completion Date: 2018-10-26

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.

Conditions

UTI - Lower Urinary Tract Infection; Antibiotic Resistant Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciprofloxacin

Ciprofloxacin for the treatment of uncomplicated urinary tract infection

Group Type: EXPERIMENTAL

Ciprofloxacin

Intervention Type: DRUG

Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.

Interventions

Ciprofloxacin

Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.

Intervention Type: DRUG

Other Intervention Names

Cipro

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Iterum Therapeutics, International Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Aronin, MD

Role: PRINCIPAL_INVESTIGATOR

Iterum Therapeutics

Locations

Restore Clinical Research

Cary, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IT004-401

Identifier Type: -

Identifier Source: org_study_id