Trial Outcomes & Findings for Single Dose Monurol for Treatment of Acute Cystitis (NCT NCT00976963)

NCT ID: NCT00976963

Last Updated: 2023-06-05

Results Overview

Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 300 participants
• Primary outcome timeframe: 28-30 days post therapy
• Results posted on: 2023-06-05

Participant Flow

Women presenting with symptoms of acute uncomplicated cystitis (AUC) at the University of Washington health center were screened for eligibility between September, 2009 to November, 2016

Of 508 AUC presenters assessed, 208 were excluded due to not meeting inclusion criteria, refusal to participate, or other reasons. 300 were enrolled and randomized to treatment intervention.

Participant milestones

Measure	TMP/SMX Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 160/800mg BID x 3 days TMP/SMX : Take one twice daily for 3 days for urinary tract infection	Fosfomycin 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately
Overall Study STARTED	150	150
Overall Study Treated With Assigned Intervention	146	150
Overall Study COMPLETED	146	150
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	TMP/SMX Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 160/800mg BID x 3 days TMP/SMX : Take one twice daily for 3 days for urinary tract infection	Fosfomycin 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately
Overall Study medication not dispensed at the pharmacy due to contraindications to the assigned therapy	2	0
Overall Study administrative error	1	0
Overall Study allergic reaction due to previously unknown allergy	1	0

Baseline Characteristics

Single Dose Monurol for Treatment of Acute Cystitis

Baseline characteristics by cohort

Measure	TMP/SMX n=147 Participants Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 160/800mg BID x 3 days TMP/SMX : Take one twice daily for 3 days for urinary tract infection	Fosfomycin n=150 Participants 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately	Total n=297 Participants Total of all reporting groups
Age, Continuous	21 years STANDARD_DEVIATION 3 • n=5 Participants	21 years STANDARD_DEVIATION 3 • n=7 Participants	21 years STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	147 Participants n=5 Participants	150 Participants n=7 Participants	297 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	18 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	140 Participants n=5 Participants	132 Participants n=7 Participants	272 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	90 Participants n=5 Participants	95 Participants n=7 Participants	185 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	39 Participants n=5 Participants	38 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Other	18 Participants n=5 Participants	17 Participants n=7 Participants	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28-30 days post therapy

Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.

Outcome measures

Measure	TMP/SMX n=146 Participants Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 160/800mg BID x 3 days TMP/SMX : Take one twice daily for 3 days for urinary tract infection	Fosfomycin n=150 Participants 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately
Number of Participants Who Were Cured	120 Participants	130 Participants

Adverse Events

TMP/SMX

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Fosfomycin

Serious events: 0 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TMP/SMX n=143 participants at risk；n=150 participants at risk Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 160/800mg BID x 3 days TMP/SMX : Take one twice daily for 3 days for urinary tract infection	Fosfomycin n=145 participants at risk；n=150 participants at risk 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately
Gastrointestinal disorders Nausea	15.4% 22/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	2.1% 3/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.
Gastrointestinal disorders Loose stools	4.9% 7/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	19.3% 28/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.
Gastrointestinal disorders Abdominal discomfort	7.0% 10/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	8.3% 12/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.
General disorders Headache	7.7% 11/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	2.1% 3/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.
General disorders Dizziness	4.9% 7/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	2.1% 3/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.
General disorders Fatigue/weakness	5.6% 8/143 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.	4.1% 6/145 • 30 days All participants enrolled (N = 150 in each arm) were monitored for mortality or serious adverse events due to inherent processes in the campus health care system. Other adverse events were collected at the 1st follow-up visit in participants who presented for this visit, and they were queried on each side effect.

Additional Information

Ann Stapleton

University of Washington

Phone: ‪(206) 880-3464‬

Email: stapl@uw.edu

Results disclosure agreements

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