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Prophylactic Antibiotics or Placebo After Hypospadias Repair (PROPHY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02096159
Recruitment Status : Active, not recruiting
First Posted : March 26, 2014
Last Update Posted : March 2, 2022
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

Study Description
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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 Phase
Hypospadias Drug: trimethoprim-sulfamethoxazole Other: placebo Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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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
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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
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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
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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
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
The Hospital for Sick Children
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Earl Y Cheng, MD, Ann & Robert H Lurie Children's Hospital of Chicago:
Study Protocol and Statistical Analysis Plan  [PDF] June 11, 2015

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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