Trial Outcomes & Findings for Efficacy of Ciprofloxacin for the Treatment of Uncomplicated Urinary Tract Infection (uUTI) (NCT NCT03366207)

Last Updated: 2019-09-06

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

250 participants

Primary outcome timeframe

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

Results posted on

2019-09-06

Participant Flow

Participant milestones

Participant milestones
Measure	Ciprofloxacin 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 Study STARTED	250
Overall Study COMPLETED	242
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciprofloxacin n=250 Participants Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	205 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 16.59 • n=5 Participants
Sex: Female, Male Female	250 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	147 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	42 Participants n=5 Participants
Race (NIH/OMB) White	202 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	250 participants n=5 Participants
Body-mass index	29.01 kg/m^2 STANDARD_DEVIATION 6.861 • n=5 Participants

PRIMARY outcome

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

Population: Microbiological modified intent to treat population

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

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=124 Participants Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Number of Subjects With Combined Clinical and Microbiologic Response	70 Participants

SECONDARY outcome

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

Population: Microbiological modified intent to treat

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

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=124 Participants Ciprofloxacin for the treatment of uncomplicated urinary tract infection Ciprofloxacin: Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
Microbiologic Response	96 Participants

Adverse Events

Ciprofloxacin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Senior Director, Clinical Development

Iterum Therapeutics

Phone: 18606614035

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER