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Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Ann & Robert H Lurie Children's Hospital of Chicago
The Hospital for Sick Children
Information provided by (Responsible Party):
Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago Identifier:
First received: March 21, 2014
Last updated: August 4, 2016
Last verified: August 2016
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 Intervention
Drug: trimethoprim-sulfamethoxazole
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Trimethoprim-sulfamethoxazole vs. Placebo After Hypospadias Repair: a Multicenter, Double-blind, Randomized Trial

Resource links provided by NLM:

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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

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

Estimated Enrollment: 630
Study Start Date: March 2014
Estimated Study Completion Date: December 2023
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02096159

Contact: Ilina Rosoklija, MPH (312) 227-6409

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   
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   
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 Identifier: NCT02096159     History of Changes
Other Study ID Numbers: LC/Uro-MF-01
Study First Received: March 21, 2014
Last Updated: August 4, 2016

Keywords provided by 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 processed this record on April 21, 2017