Health TrialsbyHealthPanel

Topical Steroids to Prevent Recurrent Urinary Tract Infections in Uncircumcised Male Infants: a Pilot Study

ConditionUrinary Tract Infection
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age0-5
SponsorBaylor College of Medicine

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • betamethasone valerate 0.1% cream

    Drug

    Steroid cream applied to the foreskin and glans twice a day for four weeks.

  • Placebo cream

    Drug

    Placebo cream is applied to the foreskin and glans twice a day for four weeks.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Participants randomized to receive steroid creamActive comparator 1 intervention
Group B: Participants randomized to receive placebo cream.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of recruitment across different settings

Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient)

Time frame
up to 2 weeks

Secondary outcomes

1

Rate of recurrent urinary tract infection

Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review.

Time frame
Between 14 days of completing antibiotics for the first urinary tract infection and through the last follow up visit, which occurs 6 months after randomization.
2

Total number of recurrent urinary tract infections

Time frame
6 month follow up period
3

Number of subsequent hospitalizations for recurrent urinary tract infections

Subsequent hospitalizations for recurrent urinary tract infections

Time frame
6 month follow up period
4

Number of subsequent emergency department visits for recurrent urinary tract infection

Subsequent emergency department visits, including urgent care, for recurrent UTI

Time frame
Within 6 month follow up period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Seattle Children's Hospital

Collaborator

Source ClinicalTrials.gov
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