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Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

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ClinicalTrials.gov Identifier: NCT02096159
Recruitment Status : Recruiting
First Posted : March 26, 2014
Last Update Posted : August 5, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

Condition or disease Intervention/treatment
Hypospadias Drug: trimethoprim-sulfamethoxazole Other: placebo

Detailed Description:
Participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. Short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 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
Study Start Date : March 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Antibiotics
trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days
Drug: trimethoprim-sulfamethoxazole
Placebo Comparator: Placebo
placebo oral suspension, 0.5 mL/kg twice daily for 10 days
Other: placebo

Outcome Measures

Primary Outcome Measures :
  1. postoperative infection [ Time Frame: up to 30 days ]
    UTI; cellulitis/wound infection

  2. wound-healing complications [ Time Frame: up to 5 years ]
    meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

Secondary Outcome Measures :
  1. adverse drug reaction [ Time Frame: up to 14 days ]
  2. C. difficile colitis [ Time Frame: up to 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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
Contacts and Locations

Information from the National Library of Medicine

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

Contact: Ilina Rosoklija, MPH (312) 227-6409 irosoklija@luriechildrens.org

United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Ilina Rosoklija, MPH    312-227-6409    irosoklija@luriechildrens.org   
Principal Investigator: Earl Y Cheng, MD         
Sub-Investigator: Dennis B Liu, MD         
Sub-Investigator: Mark A Faasse, MD, MPH         
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Rakan Odeh, MD       rakan.odeh@sickkids.ca   
Principal Investigator: Walid A Farhat, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
The Hospital for Sick Children
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
More Information

Additional Information:
Responsible Party: Earl Y Cheng, MD, Head, Division of Urology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02096159     History of Changes
Other Study ID Numbers: LC/Uro-MF-01
First Posted: March 26, 2014    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016

Keywords provided by Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Anti-Bacterial Agents

Additional relevant MeSH terms:
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors