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

NCT03366207 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IT004-401
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Combined Clinical and Microbiologic Response

  Clinical response is defined as complete resolution of uUTI symptoms at entry and no new uUTI symptoms; microbiologic success is defined as eradication of baseline pathogen

  From start of treatment until assessment of cure, approximately 12 days

Secondary Outcomes (1)

• Microbiologic Response

  From start of treatment until assessment of cure, approximately 12 days

Study Arms (1)

Ciprofloxacin

EXPERIMENTAL

Ciprofloxacin for the treatment of uncomplicated urinary tract infection

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

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

Also known as: Cipro

Ciprofloxacin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only females are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Iterum Therapeutics, International Limited: lead

Study Sites (1)

Restore Clinical Research

Cary, North Carolina, 27518, United States

Location

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Director, Clinical Development
• Organization: Iterum Therapeutics

saronin@iterumtx.com

18606614035

Study Officials

• Steven Aronin, MD

  Iterum Therapeutics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label study of ciprofloxacin for uncomplicated urinary tract infection

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 8, 2017
• Study Start: December 15, 2017
• Primary Completion: July 31, 2018
• Study Completion: October 26, 2018
• Last Updated: September 6, 2019
• Results First Posted: August 21, 2019

Record last verified: 2019-07

Locations

US (1)