Urinary Tract Infection
Conditions
Keywords
UTI
Brief summary
Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI. An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.
Detailed description
Procedures subjects will undergo once they have read and signed the consent are: Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.
Interventions
DRUGTMP/SMX
Take one twice daily for 3 days for urinary tract infection
DRUGFosfomycin
Mix sachet with 1/2 glass cold water and stir. Drink immediately
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Non pregnant women in good health with symptoms of acute cystitis for less than 7 days
Exclusion criteria
* Pregnant, lactating, or not regularly contracepting * History of chronic conditions such as diabetes * Known anatomic abnormalities of the urinary tract * Use of prophylactic antibiotics * History of allergy or intolerance to any of the study drugs * Recent (\> 2 weeks)exposure to oral or parenteral antimicrobial * History of UTI in previous 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Cured | 28-30 days post therapy | Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 147 |
| Fosfomycin 3g sachet single dose
Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately | 150 |
| Total | 297 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | administrative error | 1 | 0 |
| Overall Study | allergic reaction due to previously unknown allergy | 1 | 0 |
| Overall Study | medication not dispensed at the pharmacy due to contraindications to the assigned therapy | 2 | 0 |
Baseline characteristics
| Characteristic | Fosfomycin | Total | TMP/SMX |
|---|---|---|---|
| Age, Continuous | 21 years STANDARD_DEVIATION 3 | 21 years STANDARD_DEVIATION 3 | 21 years STANDARD_DEVIATION 3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 25 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 132 Participants | 272 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 38 Participants | 77 Participants | 39 Participants |
| Race/Ethnicity, Customized Other | 17 Participants | 35 Participants | 18 Participants |
| Race/Ethnicity, Customized White | 95 Participants | 185 Participants | 90 Participants |
| Sex: Female, Male Female | 150 Participants | 297 Participants | 147 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 46 / 143 | 43 / 145 |
| serious Total, serious adverse events | 0 / 150 | 0 / 150 |
Outcome results
Primary
Number of Participants Who Were Cured
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.
Time frame: 28-30 days post therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TMP/SMX | Number of Participants Who Were Cured | 120 Participants |
| Fosfomycin | Number of Participants Who Were Cured | 130 Participants |
Comparison: The null hypothesis is that Fosfomycin is inferior to TMP/SMX.p-value: <0.001Wald test for noninferiority