NCT02593903

Brief Summary

The purpose of this study is to evaluate the efficacy of prophylactic antibiotics following distal or mid-shaft hypospadias repair in influencing the rate of postoperative urinary tract infection and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 4, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 5, 2018

Completed
Last Updated

November 5, 2018

Status Verified

November 1, 2018

Enrollment Period

3.3 years

First QC Date

October 30, 2015

Results QC Date

September 17, 2018

Last Update Submit

November 2, 2018

Conditions

Hypospadias

Keywords

Antibiotic Prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Urinary Tract Infection

    Urinary tract infection (UTI) will be diagnosed based on urine culture positive at 50,000CFUs per mL with one or both of the following: fever \>38 Celsius, or significant fussiness and irritability with voiding per parent report. Asymptomatic bacteriuria is known and expected in this population; therefore culture positive results alone will not be sufficient to meet the definition of UTI.

    4-8 days post-operation

Study Arms (2)

Antibiotics Group

EXPERIMENTAL

Patients randomized to this arm will receive prophylactic oral antibiotics following the surgery and catheter placement (Septra, 3 mg/kg/dose once daily), and will continue the medication for until the day before catheter removal 4-8 days post-operation.

Drug: Septra

No Antibiotics Group

NO INTERVENTION

Patients randomized to this arm will receive regular clinical care without prophylactic antibiotics, including catheter placement/removal.

Interventions

SeptraDRUG
Also known as: Bactrim, Sulfamethoxazole/trimethoprim
Antibiotics Group

Eligibility Criteria

Age6 Months - 2 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • all children between ages 6 months to 2 years under going distal or mid shaft hypospadias repair
  • children of parents who give informed consent
  • English speaking
  • participant must be available for follow-up 3 and 12 months post-surgery

You may not qualify if:

  • all proximal hypospadias and redo hypospadias repairs
  • children who are allergic to sulfa medications
  • patients who have UTI at time of surgery (proven by culture)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

  • Meir DB, Livne PM. Is prophylactic antimicrobial treatment necessary after hypospadias repair? J Urol. 2004 Jun;171(6 Pt 2):2621-2. doi: 10.1097/01.ju.0000124007.55430.d3.

    PMID: 15118434BACKGROUND

  • Roth EB, Kryger JV, Durkee CT, Lingongo MA, Swedler RM, Groth TW. Antibiotic Prophylaxis with Trimethoprim-Sulfamethoxazole versus No Treatment after Mid-to-Distal Hypospadias Repair: A Prospective, Randomized Study. Adv Urol. 2018 Mar 26;2018:7031906. doi: 10.1155/2018/7031906. eCollection 2018.

    PMID: 29780414DERIVED

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

Results Point of Contact

Title
Clinical Research Coordinator
Organization
Medical College of Wisconsin
ebedjeti@mcw.edu
414-337-3441

Study Officials

  • Travis W Groth, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, MD

Study Record Dates

First Submitted

October 30, 2015

First Posted

November 2, 2015

Study Start

March 4, 2014

Primary Completion

June 30, 2017

Study Completion

April 1, 2018

Last Updated

November 5, 2018

Results First Posted

November 5, 2018

Record last verified: 2018-11

Locations

US(1)