Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 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: September 18, 2014
Last verified: September 2014
  Purpose

The primary purpose of this study is to determine if 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) 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
  • 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         
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: September 18, 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:
Hypospadias
Congenital Abnormalities
Genital Diseases, Male
Penile Diseases
Urogenital Abnormalities
Sulfamethoxazole
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014