NCT02096159

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

4.8 years

First QC Date

March 21, 2014

Last Update Submit

November 12, 2024

Conditions

Hypospadias

Keywords

HypospadiasAnti-Bacterial Agents

Outcome Measures

Primary Outcomes (2)

  • postoperative infection

    Urinary tract infection; cellulitis/wound infection

    up to 30 days

  • wound-healing complications

    meatal stenosis; urethral stricture; urethrocutaneous fistula; dehiscence; urethral diverticulum

    up to 5 years

Secondary Outcomes (2)

  • adverse drug reaction

    up to 14 days

  • C. difficile colitis

    up to 6 months

Study Arms (2)

Antibiotics

EXPERIMENTAL

trimethoprim-sulfamethoxazole oral suspension, 4 mg/kg (0.5 mL/kg) twice daily for 10 days

Drug: trimethoprim-sulfamethoxazole

Placebo

PLACEBO COMPARATOR

placebo oral suspension, 0.5 mL/kg twice daily for 10 days

Other: placebo

Interventions

trimethoprim-sulfamethoxazoleDRUG
Antibiotics
placeboOTHER
Placebo

Eligibility Criteria

AgeUp to 5 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (1)

  • Faasse MA, Farhat WA, Rosoklija I, Shannon R, Odeh RI, Yoshiba GM, Zu'bi F, Balmert LC, Liu DB, Alyami FA, Beaumont JL, Erickson DL, Gong EM, Johnson EK, Judd S, Kaplan WE, Kaushal G, Koyle MA, Lindgren BW, Maizels M, Marcus CR, McCarter KL, Meyer T, Qureshi T, Saunders M, Thompson T, Yerkes EB, Cheng EY. Randomized trial of prophylactic antibiotics vs. placebo after midshaft-to-distal hypospadias repair: the PROPHY Study. J Pediatr Urol. 2022 Apr;18(2):171-177. doi: 10.1016/j.jpurol.2022.01.008. Epub 2022 Jan 25.

    PMID: 35144885DERIVED

MeSH Terms

Conditions

Hypospadias

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Urogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

SulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of Urology

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

March 1, 2014

Primary Completion

December 1, 2018

Study Completion

August 1, 2025

Last Updated

November 14, 2024

Record last verified: 2024-11

Locations

US(1)CA(1)