Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)
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ClinicalTrials.gov Identifier: NCT02096159 |
Recruitment Status :
Active, not recruiting
First Posted : March 26, 2014
Last Update Posted : March 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hypospadias | Drug: trimethoprim-sulfamethoxazole Other: placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial |
Actual Study Start Date : | March 2014 |
Actual Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | June 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Antibiotics
trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days
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Drug: trimethoprim-sulfamethoxazole |
Placebo Comparator: Placebo
placebo oral suspension, 0.5 mL/kg twice daily for 10 days
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Other: placebo |
- postoperative infection [ Time Frame: up to 30 days ]UTI; cellulitis/wound infection
- wound-healing complications [ Time Frame: up to 5 years ]meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum
- adverse drug reaction [ Time Frame: up to 14 days ]
- C. difficile colitis [ Time Frame: up to 6 months ]

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Ages Eligible for Study: | up to 5 Years (Child) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- mid-to-distal shaft hypospadias
- single-stage hypospadias repair
- length of urethral repair (urethroplasty) less than or equal to 20 mm
- placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively
Exclusion Criteria:
- previous hypospadias repair
- prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
- cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
- any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease)
- use of antibiotics within seven days prior to hypospadias repair
- foreskin reconstruction at the time of hypospadias repair
- prescription of oral antibiotics other than Study Medication at the time of hypospadias repair

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096159
United States, Illinois | |
Ann & Robert H Lurie Children's Hospital of Chicago | |
Chicago, Illinois, United States, 60611 | |
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Earl Y Cheng, MD | Ann & Robert H Lurie Children's Hospital of Chicago | |
Principal Investigator: | Mark A Faasse, MD, MPH | Ann & Robert H Lurie Children's Hospital of Chicago |
Documents provided by Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Responsible Party: | Earl Y Cheng, MD, Head, Division of Urology, Ann & Robert H Lurie Children's Hospital of Chicago |
ClinicalTrials.gov Identifier: | NCT02096159 |
Other Study ID Numbers: |
LC/Uro-MF-01 |
First Posted: | March 26, 2014 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Hypospadias Anti-Bacterial Agents |
Hypospadias Penile Diseases Urogenital Abnormalities Congenital Abnormalities Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Sulfamethoxazole Anti-Infective Agents, Urinary Anti-Infective Agents Renal Agents |
Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors Anti-Bacterial Agents |