← Back to Search

trimethoprim-sulfamethoxazole for Hypospadias (PROPHY Trial)

N/A

Waitlist Available

Led By Earl Y Cheng, MD

Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

PROPHY Trial Summary

This trial will see if it's beneficial to give routine antibiotics to patients after fixing mid-to-distal hypospadias.

PROPHY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

postoperative infection

wound-healing complications

Secondary outcome measures

C. difficile colitis

adverse drug reaction

PROPHY Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AntibioticsExperimental Treatment1 Intervention

trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Group II: PlaceboPlacebo Group1 Intervention

placebo oral suspension, 0.5 mL/kg twice daily for 10 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

trimethoprim-sulfamethoxazole

2020

Completed Phase 4

~2920

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenOTHER

684 Previous Clinical Trials

6,944,903 Total Patients Enrolled

Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor

253 Previous Clinical Trials

5,187,635 Total Patients Enrolled

Earl Y Cheng, MDPrincipal InvestigatorAnn & Robert H Lurie Children's Hospital of Chicago

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have been conducted involving trimethoprim-sulfamethoxazole?

"Presently, 16 clinical trials related to trimethoprim-sulfamethoxazole are underway. Of these active studies, 3 have reached Phase 3. Research on this treatment is predominantly being conducted in Montreal but there are 39 other locations where it is being studied as well."

Answered by AI

In what medical contexts is trimethoprim-sulfamethoxazole most often recommended?

"Typically, trimethoprim-sulfamethoxazole is prescribed to treat shigella sonnei based enteritis infections. Additionally, this medication can alleviate otitis media, cholera and shigellosis symptoms."

Answered by AI

Are there still opportunities for prospective participants to sign up for this clinical research?

"This particular trial is not presently accepting candidates. It was initially launched on March 1st 2014 and the latest update to its description was made on February 11th 2022. Nevertheless, there are 14 open clinical studies recruiting patients with hypospadias and 16 trials looking for participants taking trimethoprim-sulfamethoxazole that may be of interest."

Answered by AI

How many individuals are being administered the experimental treatment as part of this trial?

"This clinical trial is no longer recruiting participants. The initial posting was on March 1st, 2014 and the last update was February 11th, 2022. Alternatives studies include 14 trials for hypospadias and 16 treatments using trimethoprim-sulfamethoxazole that are currently enrolling patients."

Answered by AI

Recent research and studies

Journal of Pediatric UrologyJournal

Randomized Trial of Prophylactic Antibiotics Vs. Placebo After Midshaft-to-distal Hypospadias Repair: The PROPHY Study

Faasse, Mark A., Walid A. Farhat, Ilina Rosoklija, Rachel Shannon, Rakan I. Odeh, Grace M. Yoshiba, Fadi Zu'bi, et al.. 2022. “Randomized Trial of Prophylactic Antibiotics Vs. Placebo After Midshaft-to-distal Hypospadias Repair: The PROPHY Study”. Journal of Pediatric Urology. Elsevier BV. doi:10.1016/j.jpurol.2022.01.008.

Journal of Pediatric UrologyJournal

Randomized Trial of Prophylactic Antibiotics Vs. Placebo After Midshaft-to-distal Hypospadias Repair: The PROPHY Study

clinicaltrials.govStudy

Prophylactic Antibiotics or Placebo After Hypospadias Repair

Earl Y Cheng, MD 2014. "Prophylactic Antibiotics or Placebo After Hypospadias Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02096159.