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

Antibiotic Resistant Infection Clinical Trial

Official title:

Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366207
• Other study ID #: IT004-401
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: October 26, 2018

Study information

• Verified date: July 2019
• Source: Iterum Therapeutics, International Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 26, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Infection
• Urinary Tract Infections
• UTI - Lower Urinary Tract Infection

Intervention

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

Locations

Country	Name	City	State
United States	Restore Clinical Research	Cary	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Iterum Therapeutics, International Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Microbiologic Response	Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit	From start of treatment until assessment of cure, approximately 12 days