Urinary Tract Infection
Conditions
Keywords
urinary tract infection, uncircumcised male infants, betamethasone cream, steroid cream
Brief summary
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.
Detailed description
This is a multi-center pilot study involving recruitment of uncircumcised male infants \< 6 months of age from outpatient clinics, emergency department and inpatient settings in Houston, Texas. Additionally, the pilot study will involve recruitment of hospitalized infants from Seattle Children's Hospital in Seattle, Washington. Various strategies for screening and recruitment will be piloted across settings to identify the most effective processes for the future study. Hospitalized infants would be enrolled prior to discharge. Children recruited from the clinic or emergency department would be enrolled in the Texas Children's Hospital Clinical Research Center. Randomization would occur after enrollment and would be conducted by the investigational pharmacy. The research investigators will teach the legal guardians of the infants how to apply the cream. The first follow up visit would occur after completion of the cream treatment and would be 28-38 days after being enrolled or after hospital discharge, whichever came later. The last follow up visit would occur 6-7 months after being enrolled or hospital discharge.
Interventions
Steroid cream applied to the foreskin and glans twice a day for four weeks.
DRUGPlacebo cream
Placebo cream is applied to the foreskin and glans twice a day for four weeks.
Sponsors
Baylor College of Medicine
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
0 Months to 5 Months
Healthy volunteers
No
Inclusion criteria
1. Uncircumcised male infants \< 6 months old 2. Both physician and laboratory confirmed diagnosis of first UTI 3. Fever (temperature ≥38.0 C) or hypothermia (temperature \<36.0 C) per ED/hospitalization or parental report
Exclusion criteria
1. Legal guardian not available to provide informed consent 2. Infant in Child Protective Services (CPS) custody 3. Legal guardian would like Urology referral for circumcision 4. Circumcision is medically indicated due to recurrent episodes of balanitis or ballooning of foreskin during urination 5. Past diagnosis of penile abnormalities (diagnoses of epispadius, hypospadias or congenital penile curvature (chordee)) 6. Prior use of topical steroid therapy for phimosis 7. History of hypersensitivity to topical steroids 8. Legal guardian is not fluent in English OR Spanish 9. Foreskin assessed to be fully retractable 10. Open wounds present on penis or in groin region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment across different settings | up to 2 weeks | Defined as the consent rate of \>= 20% as stratified by setting (clinic/EC/inpatient) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of recurrent urinary tract infection | 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. | Defined as at least one subsequent urinary tract infection as confirmed through parent report and medical record review. |
| Total number of recurrent urinary tract infections | 6 month follow up period | — |
| Number of subsequent hospitalizations for recurrent urinary tract infections | 6 month follow up period | Subsequent hospitalizations for recurrent urinary tract infections |
| Number of subsequent emergency department visits for recurrent urinary tract infection | Within 6 month follow up period | Subsequent emergency department visits, including urgent care, for recurrent UTI |
| Rate of provider diagnosed recurrent urinary tract infection | 6 month follow up period | Number of recurrent urinary tract infections that are diagnosed by the physician but do not necessarily meet laboratory criteria for urinary tract infection. |
| Number of Lumbar punctures | 6 month follow up period | Number of lumbar punctures received during a subsequent emergency department visit or hospitalization for recurrent urinary tract infection |
| Self reported Rate of Referral for Circumcision | During the 6 month follow up period | Parent reports referral to Urology for circumcision or circumcision performed within the 6 month follow up period. |
| Self Reported Adherence to Applying Topical Cream Regimen | Measured at 4 week follow up visit | Adherence to applying the topical cream measured by asking the frequency of application in a questionnaire completed by the legal guardian. |
| Rate of Adverse effects of cream | At 4 weeks | Local or systemic side effects of the cream (e.g., irritation, local infection) |
| Number of infants with Congenital anomalies of the kidney and urinary tract | From time of enrollment through last follow up visits 6 months later | Number of participants with previously known or newly diagnosed genitourinary anomalies |
| Number of subsequent clinic visits for recurrent urinary tract infection | During the 6 month follow up period | Subsequent clinic visits may include visits to the primary care physician or another physician in the clinic |
| Attrition rate | Through the 6 month follow up period for each participant | Total number of missed visits at 4 weeks and 6 months. This will be measured by tracking of study visits. |
| Parental acceptability of the study design | At the 6 month follow up visit for each participant | Perceptions on any facilitators and barriers to participating in the study as related to enrollment, administration of the study cream and attending follow up visits. Qualitatively measured using semi-structured interviews. |
Countries
United States
Contacts
CONTACTSowdhamini Wallace, DO, MS
Outcome results
None listed