Trial Outcomes & Findings for Cefpodoxime vs Ciprofloxacin for Acute Cystitis (NCT NCT00194532)

Results Overview

Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

28-30 days post therapy

Results posted on

2014-06-10

Participant Flow

Participant milestones

Participant milestones
Measure	Ciprofloxacin Ciprofloxacin 250 mg BID X 3 days	Cefpodoxime Cefpodoxime 100 mg BID X 3 days
Overall Study STARTED	150	150
Overall Study COMPLETED	150	150
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cefpodoxime vs Ciprofloxacin for Acute Cystitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ciprofloxacin n=150 Participants Ciprofloxacin 250 mg BID X 3 days	Cefpodoxime n=150 Participants Cefpodoxime 100 mg BID X 3 days	Total n=300 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	23 years n=7 Participants	24 years n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	150 Participants n=7 Participants	300 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	150 participants n=5 Participants	150 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 28-30 days post therapy

Population: modified ITT

Participants with clinical cure, i.e. free of urinary tract symptoms and requiring no further antibiotic treatment, to assess the efficacy of a 3-day regimen of cefpodoxime compared to ciprofloxacin

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=150 Participants Ciprofloxacin 250 mg BID X 3 days	Cefpodoxime n=150 Participants Cefpodoxime 100 mg BID X 3 days
Clinical Cure Cure	140 participants	123 participants
Clinical Cure Not cure	10 participants	27 participants

SECONDARY outcome

Timeframe: 1-15 days post therapy

Population: Per protocol. Participants were eligible for analysis if they had an enrollment urine containing uropathogens and a urine specimen taken at follow-up.

Elimination or decrease of causative uropathogen(s) in the mid-stream urine culture at follow-up

Outcome measures

Outcome measures
Measure	Ciprofloxacin n=128 Participants Ciprofloxacin 250 mg BID X 3 days	Cefpodoxime n=129 Participants Cefpodoxime 100 mg BID X 3 days
Microbiologic Cure Cure	123 participants	104 participants
Microbiologic Cure Not cure	5 participants	25 participants

Adverse Events

Ciprofloxacin

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Cefpodoxime

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ciprofloxacin n=137 participants at risk；n=150 participants at risk Ciprofloxacin 250 mg BID X 3 days	Cefpodoxime n=137 participants at risk；n=150 participants at risk Cefpodoxime 100 mg BID X 3 days
Gastrointestinal disorders gastrointestinal(GI) side effects	16.8% 23/137 • Number of events 30	15.3% 21/137 • Number of events 26
Nervous system disorders central nervous system (CNS) side effect	12.4% 17/137 • Number of events 18	10.9% 15/137 • Number of events 16
Reproductive system and breast disorders vaginal side effects	5.8% 8/137 • Number of events 8	5.1% 7/137 • Number of events 7
Gastrointestinal disorders nausea	9.5% 13/137 • Number of events 13	5.8% 8/137 • Number of events 8
Gastrointestinal disorders loose stools	5.1% 7/137 • Number of events 7	6.6% 9/137 • Number of events 9
Gastrointestinal disorders abdominal discomfort	5.1% 7/137 • Number of events 7	5.1% 7/137 • Number of events 7
Nervous system disorders headache	2.9% 4/137 • Number of events 4	5.1% 7/137 • Number of events 7

Additional Information

Ann Stapleton, MD

University Of Washington

Phone: 206-616-4121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place