Topical Steroids for UTI Prevention in Infants

(STRUMI-T Trial)

Recruiting at 2 trial locations

Overseen By Sowdhamini Wallace, DO, MS

Age: < 18

Sex: Male

Trial Phase: Phase 4

Sponsor: Baylor College of Medicine

Must not be taking: Topical steroids

Disqualifiers: Penile abnormalities, Fully retractable foreskin, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Male infants, who are enrolled in this study, would receive either the steroid cream or a placebo cream (a look alike cream without steroids). The cream would be applied twice a week for four weeks. Then there would be two follow up visits with the research team to measure whether the infant experienced any urinary tract infections and to measure parent perceptions of their experience participating in the study.

Are You a Good Fit for This Trial?

Inclusion Criteria

Fever (temperature ≥38.0 C) or hypothermia (temperature <36.0 C) per ED/hospitalization or parental report

I am an uncircumcised male infant younger than 6 months old.

I have had my first UTI confirmed by my doctor and lab tests.

Exclusion Criteria

Legal guardian not available to provide informed consent

Infant in Child Protective Services (CPS) custody

I have been diagnosed with a penile abnormality such as epispadius, hypospadias, or chordee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 2 weeks

Treatment

Participants receive either the steroid cream or placebo cream applied twice a week for four weeks

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measuring urinary tract infections and parent perceptions

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Betamethasone Valerate

How Is the Trial Designed?

Group I: Participants randomized to receive steroid cream Active Control 1 Intervention

Group II: Participants randomized to receive placebo cream. Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Seattle Children's Hospital

Collaborator

Trials

319

Recruited

5,232,000+