Prophylactic Antibiotics for Hypospadias

(PROPHY Trial)

Not currently recruiting at 1 trial location

Age: < 18

Sex: Male

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must not be taking: Antibiotics

Disqualifiers: Previous repair, Allergic reaction, Infection risk, others

Compensation: Varies

Number of Visits: Unknown

Duration: 10 days

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if preventive antibiotics after surgery for mid-to-distal hypospadias (a condition where the urethra's opening is not at the tip of the penis) are beneficial. Participants will receive either a placebo (a harmless pill with no active drug) or trimethoprim-sulfamethoxazole (an antibiotic) to assess any differences. Individuals who have undergone a single-stage repair for this type of hypospadias and meet specific criteria, such as having a urethral repair of 20 mm or less, may qualify to participate. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance post-surgical care for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot use antibiotics within seven days before the hypospadias repair or take oral antibiotics other than the study medication during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the antibiotic trimethoprim-sulfamethoxazole, tested in this trial, has been used safely in past studies. In these studies, patients taking this antibiotic experienced fewer cases of pus in their urine, a sign of infection, compared to those who did not take it. This suggests the antibiotic is effective and generally well-tolerated.

Furthermore, trimethoprim-sulfamethoxazole is widely used for various conditions, enhancing its safety profile. No serious side effects were reported in these studies, indicating that the treatment is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Trimethoprim-sulfamethoxazole is unique because it combines two antibiotics to prevent infections following hypospadias surgery. Unlike the standard practice, which might not routinely use prophylactic antibiotics post-surgery, this treatment aims to reduce infection risk with a specific dosage regimen over just 10 days. Researchers are excited about this approach because it could offer a targeted, efficient way to protect against infections, potentially improving recovery outcomes for patients.

What evidence suggests that this trial's treatments could be effective for hypospadias?

This trial will compare the effects of trimethoprim-sulfamethoxazole with a placebo in preventing urinary tract infections after hypospadias surgery. Research has shown that the antibiotic trimethoprim-sulfamethoxazole might help lower the risk of such infections. In one study, patients who took this antibiotic had less pus in their urine, indicating reduced infection. However, another study found no significant reduction in infection rates or complications after surgery compared to a placebo. This mixed evidence suggests that while there may be some benefits, the treatment's effectiveness remains uncertain. ^{1 2 3 6 7}

Who Is on the Research Team?

Earl Y Cheng, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Mark A Faasse, MD, MPH

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for boys with mid-to-distal shaft hypospadias who are getting a single-stage repair and an open-drainage urethral stent for 5-10 days. It's not for those who've had previous repairs, have allergies to trimethoprim-sulfamethoxazole, take conflicting meds, or have conditions like HIV/AIDS that increase infection risk.

Inclusion Criteria

My hypospadias is located in the middle or near the tip of my penis.

I had a one-time surgery for hypospadias.

My urethral repair was 20 mm or shorter.

Exclusion Criteria

Prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole

I have not taken antibiotics within the last week before my hypospadias surgery.

I had foreskin reconstruction during my hypospadias surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Participants are monitored for long-term outcomes such as wound-healing complications

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Trimethoprim-sulfamethoxazole

Trial Overview The study is testing if giving preventive antibiotics (trimethoprim-sulfamethoxazole) after hypospadias surgery helps more than a placebo. Boys will be randomly given either the antibiotic or placebo to see which works better at preventing complications.

How Is the Trial Designed?

Group I: Antibiotics Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5892261/

Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole ... Demographics, severity of hypospadias, and type of repair were similar between the groups. Patients in the treatment group had significantly less pyuria (18%) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02096159

Prophylactic Antibiotics or Placebo After Hypospadias Repair Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and ...

3. withpower.com withpower.com/trial/prophylactic-antibiotics-for-hypospadias-2ae2e

Prophylactic Antibiotics for Hypospadias (PROPHY Trial) Research shows that using Trimethoprim-sulfamethoxazole as a preventive measure after hypospadias surgery can help reduce the risk of urinary tract infections ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29780414/

Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole ... Secondary outcomes included symptomatic urinary tract infection and postoperative complications. Results: 70 patients consented to the study ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1477513122000110

Randomized trial of prophylactic antibiotics vs. placebo ... In this placebo-controlled trial of 93 patients, prophylactic antibiotics were not found to reduce infection or urethroplasty complications after stented mid- ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02593903

Antibiotic Use Following Distal and Mid-shaft Hypospadias ... The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S147751312030663X

Comparative analysis of perioperative prophylactic ... We conducted a retrospective study of consecutive patients over a 6-year period with distal penile hypospadias treated with urethral stenting.