NCT04489979

Brief Summary

Some children are admitted to pediatric emergency department due to epididymitis or orchitis. Some of them are treated by analgetics only whie some are treated by analgetics with antibiotics. The study will compare clinical presentation between groups and will compare pediatric urologic outpatient clinic follow up findings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 28, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 17, 2021

Status Verified

August 1, 2021

Enrollment Period

10 months

First QC Date

February 29, 2020

Last Update Submit

August 16, 2021

Conditions

Epididymitis Orchitis

Outcome Measures

Primary Outcomes (1)

  • Healing

    No symptoms any more

    1 month

Study Arms (2)

Analgetics only

Children with epididymitis / orchitis treated by analgetics only.

Other: Antibiotics

Analgetics and antibiotics

Children with epididymitis / orchitis treated by analgetics and antibiotics.

Other: Antibiotics

Interventions

AntibioticsOTHER

Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.

Analgetics and antibioticsAnalgetics only

Eligibility Criteria

AgeUp to 18 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly males have testicles
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male children who were admitten to pediatric emergency department due to epididymitis or orchitis

You may qualify if:

  • All children admitted to pediatric emergency department due to epididymitis or orchitis

You may not qualify if:

  • No sonographic or laboratory exam
  • Antibiotic treatment before diagnosis
  • No outpatient follow-up
  • Known urologic congenital malformations
  • Admission to inpatient department or emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe medical center

Hadera, Hadera, 38100, Israel

Location

Related Publications (1)

  • Lau P, Anderson PA, Giacomantonio JM, Schwarz RD. Acute epididymitis in boys: are antibiotics indicated? Br J Urol. 1997 May;79(5):797-800. doi: 10.1046/j.1464-410x.1997.00129.x.

    PMID: 9158522BACKGROUND

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Erez Nadir, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

February 29, 2020

First Posted

July 28, 2020

Study Start

March 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

August 17, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)