Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
Collaborator:
The Hospital for Sick Children
Information provided by (Responsible Party):
Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT02096159
First received: March 21, 2014
Last updated: April 13, 2014
Last verified: April 2014
  Purpose

The primary purpose of this study is to determine whether routine use of prophylactic (preventive) antibiotics is beneficial or unnecessary after hypospadias repair.


Condition Intervention
Hypospadias
Drug: trimethoprim-sulfamethoxazole
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 1 month ] [ Designated as safety issue: No ]
  • wound-healing complications [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum


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

Estimated Enrollment: 630
Study Start Date: March 2014
Estimated Study Completion Date: July 2022
Estimated Primary Completion Date: December 2017 (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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mid-to-distal shaft hypospadias
  • single-stage hypospadias repair with circumcision
  • length of urethral repair (urethroplasty) no greater than 20 mm
  • placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting of 5-10 days post-operatively

Exclusion Criteria:

  • previous hypospadias or other penile surgery, including circumcision
  • prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole
  • cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole
  • HIV/AIDS, poorly controlled diabetes mellitus or other immunocompromising conditions
  • 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 ClinicalTrials.gov identifier: NCT02096159

Contacts
Contact: Mark A Faasse, MD (312) 227-6743 mfaasse@luriechildrens.org
Contact: Theresa Meyer, MS, RN, CPN (312) 227-6734 tmeyer@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark A Faasse, MD    312-227-6743    mfaasse@luriechildrens.org   
Contact: Theresa Meyer, MS, RN, CPN    (312) 227-6734    tmeyer@luriechildrens.org   
Principal Investigator: Earl Y Cheng, MD         
Sub-Investigator: Dennis B Liu, MD         
Sub-Investigator: Mark A Faasse, MD         
Canada, Ontario
The Hospital for Sick Children Not yet recruiting
Toronto, Ontario, Canada, M5G 1X8
Principal Investigator: Walid A Farhat, MD         
Sub-Investigator: Joseph M Gleason, MD         
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
The Hospital for Sick Children
Investigators
Principal Investigator: Earl Y Cheng, MD Ann & Robert H Lurie Children's Hospital of Chicago
Study Director: Mark A Faasse, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Additional Information:
No publications provided

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
Study First Received: March 21, 2014
Last Updated: April 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Hypospadias
Anti-Bacterial Agents

Additional relevant MeSH terms:
Urethral Diseases
Hypospadias
Epispadias
Penile Diseases
Genital Diseases, Male
Urogenital Abnormalities
Congenital Abnormalities
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014