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New treatment option for Urinary Tract Infection
Official title Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study
ClinicalTrials.gov ID: NCT07508124
What this study is testing
What is betamethasone valerate 0.1% cream?
betamethasone valerate 0.1% cream is an investigational medicine, given as a twice-daily treatment applied to the skin, being studied as a potential treatment for urinary tract infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this smaller clinical trial is to evaluate the study design of this research to help prepare for a larger research study in the future. The future larger study would focus on whether steroid cream can reduce recurrent urinary tract infections in male infants, who are not circumcised.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 5, men only
You may be able to join if
- Uncircumcised male infants \< 6 months old
- Both physician and laboratory confirmed diagnosis of first UTI
- Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report
You likely can't join if
- Legal guardian not available to provide informed consent
- Infant in Child Protective Services (CPS) custody
- Legal guardian would like Urology referral for circumcision
- Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
- Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
- Prior use of topical steroid therapy for phimosis
See the full eligibility criteria
- Uncircumcised male infants \< 6 months old
- Both physician and laboratory confirmed diagnosis of first UTI
- Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report
- Legal guardian not available to provide informed consent
- Infant in Child Protective Services (CPS) custody
- Legal guardian would like Urology referral for circumcision
- Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination
- Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee))
- Prior use of topical steroid therapy for phimosis
- History of hypersensitivity to topical steroids
- Legal guardian is not fluent in English OR Spanish
- Foreskin assessed to be fully retractable
- Open wounds present on penis or in groin region
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Katy, Texas, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 0 months to 5 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Katy, Texas, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.