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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMP/SMX | Active Comparator | Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days |
|
| Fosfomycin | Experimental | 3g sachet single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMP/SMX | Drug | Take one twice daily for 3 days for urinary tract infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Cured | Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach. | 28-30 days post therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ann E. Stapleton, M.D. | University of WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Fosfomycin | 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who were dispensed the treatment intervention, completed some or all of the treatment intervention and were included in the summary of side effects.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Fosfomycin | 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Were Cured | Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach. | Posted | Count of Participants | Participants | 28-30 days post therapy |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
The clinicians and participants were not blinded as to the assigned intervention.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ann Stapleton | University of Washington | ‪(206) 880-3464‬ | stapl@uw.edu |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D015662 | Trimethoprim, Sulfamethoxazole Drug Combination |
| D005578 | Fosfomycin |
| ID | Term |
|---|---|
| D013420 | Sulfamethoxazole |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
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| Fosfomycin | Drug | Mix sachet with 1/2 glass cold water and stir. Drink immediately |
|
|
| allergic reaction due to previously unknown allergy |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 46 |
| 143 |
| EG001 | Fosfomycin | 3g sachet single dose Fosfomycin: Mix sachet with 1/2 glass cold water and stir. Drink immediately | 0 | 150 | 0 | 150 | 43 | 145 |
| Loose stools | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Fatigue/weakness | General disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009930 |
| Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D014295 | Trimethoprim |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |