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

• Sponsor: Iterum Therapeutics, International Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03366207
• Collaborator: (none)
• Enrollment: 250
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 24.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
UTI - Lower Urinary Tract Infection; Antibiotic Resistant Infection	Drug: Ciprofloxacin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 250 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Open label study of ciprofloxacin for uncomplicated urinary tract infectionOpen label study of ciprofloxacin for uncomplicated urinary tract infection
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical and Microbiologic Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection in Adult Women.
• Actual Study Start Date: Dec 15, 2017
• Actual Primary Completion Date: Jul 31, 2018
• Actual Study Completion Date: Oct 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ciprofloxacin Ciprofloxacin for the treatment of uncomplicated urinary tract infection	Drug: Ciprofloxacin; Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.; Other Names: Cipro

Outcome Measures

Primary Outcome Measures

1. Number of Subjects With Combined Clinical and Microbiologic Response [From start of treatment until assessment of cure, approximately 12 days]

   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

Secondary Outcome Measures

1. Microbiologic Response [From start of treatment until assessment of cure, approximately 12 days]

   Microbiologic response is defined as demonstrating <1000 colony-forming units per mL of the baseline uropathogen at the test of cure visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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:

4. a dipstick analysis positive for nitrite AND

5. a dipstick analysis positive for leukocyte esterase

6. 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

1. 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

2. Concurrent use of non-study antibacterial drug therapy that would have a potential effect on outcome evaluations in patients with uUTI

3. Patients with ileal loops or urinary stoma

4. Patients with an indwelling urinary catheter in the previous 30 days

5. Patients with paraplegia

6. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)

7. Any history of trauma to the pelvis or urinary tract

8. 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

9. Patient's urine culture results, if available at study entry, identifies the causative uropathogen for the presenting illness to be resistant to ciprofloxacin

10. Patient has severe chronic kidney disease, or is receiving hemodialysis or peritoneal dialysis or had a renal transplant

11. Patient is known to have severe neutropenia

12. Patient is known to be pregnant

13. Patients with uncontrolled diabetes mellitus

14. Patients with a known history of myasthenia gravis

15. Patients who require concomitant administration of tizanidine

16. Patients with a history of allergy to quinolones

17. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Restore Clinical Research	Cary	North Carolina	United States	27518

Sponsors and Collaborators

• Iterum Therapeutics, International Limited

Investigators

• Principal Investigator: Steven Aronin, MD, Iterum Therapeutics

Study Documents (Full-Text)

• Study Protocol - Mar 27, 2018
• Statistical Analysis Plan - Jul 30, 2019

More Information

Publications

None provided.

• Responsible Party: Iterum Therapeutics, International Limited
• ClinicalTrials.gov Identifier: NCT03366207
• Other Study ID Numbers: IT004-401
• First Posted: Dec 8, 2017
• Last Update Posted: Sep 6, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Ciprofloxacin

Study Results

Participant Flow

Arm/Group Title	Ciprofloxacin
Arm/Group Description	Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Period Title: Overall Study
STARTED	250
COMPLETED	242
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Ciprofloxacin
Arm/Group Description	Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Overall Participants	250
Age (Count of Participants)
<=18 years	2 0.8%
Between 18 and 65 years	205 82%
>=65 years	43 17.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.3 (16.59)
Sex: Female, Male (Count of Participants)
Female	250 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	147 58.8%
Not Hispanic or Latino	98 39.2%
Unknown or Not Reported	5 2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	4 1.6%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	42 16.8%
White	202 80.8%
More than one race	0 0%
Unknown or Not Reported	2 0.8%
Region of Enrollment (participants) [Number]
United States	250 100%
Body-mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.01 (6.861)

Outcome Measures

1. Primary Outcome

Title	Number of Subjects With Combined Clinical and Microbiologic Response
Description	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
Time Frame	From start of treatment until assessment of cure, approximately 12 days

Outcome Measure Data

Analysis Population Description

Microbiological modified intent to treat population

Arm/Group Title	Ciprofloxacin
Arm/Group Description	Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Measure Participants	124
Count of Participants [Participants]	70 28%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

Microbiological modified intent to treat

Arm/Group Title	Ciprofloxacin
Arm/Group Description	Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Measure Participants	124
Count of Participants [Participants]	96 38.4%

Adverse Events

Time Frame	From start of treatment until assessment of cure, approximately 12 days
Arm/Group Title	Ciprofloxacin
Arm/Group Description	Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
All Cause Mortality
	Ciprofloxacin
	Affected / at Risk (%)	# Events
Total	0/242 (0%)
Serious Adverse Events
	Ciprofloxacin
	Affected / at Risk (%)	# Events
Total	0/242 (0%)
Other (Not Including Serious) Adverse Events
	Ciprofloxacin
	Affected / at Risk (%)	# Events
Total	0/242 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigator may publish/present results provided the following are satisfied: (i) Sponsor consents to publication; (ii) Multi-Center Publication published; or at least 18 months since database lock; (iii) investigator must submit proposed publication to Sponsor for review, allowing at least 60 days to review. The Investigator shall delay publication/presentation for up to 45 days to permit the Sponsor time to obtain Intellectual Property protections and protect confidential information.