Urinary Tract InfectionNCT00976963
Single Dose Monurol for Treatment of Acute Cystitis
A study testing TMP/SMX and Fosfomycin in people with Urinary Tract Infection, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- TMP/SMX and Fosfomycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2009to 27 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non pregnant women in good health with symptoms of acute cystitis for less than 7 days
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Urinary Tract Infection
- Being tested
- TMP/SMX, Fosfomycin
- Keywords
- UTI
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMP/SMXDrug
Also called Septra, Bactrim
Take one twice daily for 3 days for urinary tract infection
FosfomycinDrug
Also called Monurol
Mix sachet with 1/2 glass cold water and stir. Drink immediately
| Study group | Role | What they receive |
|---|---|---|
| TMP/SMX | Active comparator | Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days Receives: Drug: TMP/SMX |
| Fosfomycin | Experimental | 3g sachet single dose Receives: Drug: Fosfomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Cured
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.
Measured: 28-30 days post therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study start17 Sep 2009
- Primary completion27 Dec 2016
- Study completion27 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ann Stapleton, University of Washington
- Investigators
- Ann E. Stapleton, M.D., Principal investigator, University of WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976963
- Sponsor's protocol ID
- 34776
- Status last verified
- Jun 2023
- First submitted
- 11 Sep 2009
- Last updated
- 5 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Monurol for Treatment of Acute Cystitis
- ClinicalTrials.gov ID
- NCT00976963
- Acronym / sponsor ID
- 34776
- Conditions
- Urinary Tract Infection
- Keywords
- UTI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 17 Sep 2009 (actual)
- Primary completion
- 27 Dec 2016 (actual)
- Study completion
- 27 Dec 2016 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Posted 5 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TMP/SMX | Active comparator | Drug: TMP/SMXSulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days |
| Fosfomycin | Experimental | Drug: Fosfomycin3g sachet single dose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non pregnant women in good health with symptoms of acute cystitis for less than 7 days
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMP/SMXAlso: Septra, BactrimTake one twice daily for 3 days for urinary tract infection | Drug | TMP/SMX |
| FosfomycinAlso: MonurolMix sachet with 1/2 glass cold water and stir. Drink immediately | Drug | Fosfomycin |
Primary outcome
Number of Participants Who Were Cured
Time frame: 28-30 days post therapy
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann E. Stapleton, M.D. principal investigator
University of WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMP/SMX and Fosfomycin in people with Urinary Tract Infection, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Were Cured (time frame: 28-30 days post therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.