Epididymitis OrchitisNCT04489979
Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis
An observational study of Epididymitis Orchitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years, men only
- Conditions the study is for
- Epididymitis Orchitis
- What is being tested?
- Antibiotics
- How many people
- 72 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Male children who were admitten to pediatric emergency department due to epididymitis or orchitis
Who may be able to join
- All children admitted to pediatric emergency department due to epididymitis or orchitis
Who cannot join
- No sonographic or laboratory exam
- Antibiotic treatment before diagnosis
- No outpatient follow-up
- Known urologic congenital malformations
- Admission to inpatient department or emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Epididymitis Orchitis
- Being tested
- Antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsOther
Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.
| Study group | Role | What they receive |
|---|---|---|
| Analgetics only | Children with epididymitis / orchitis treated by analgetics only. Receives: Other: Antibiotics | |
| Analgetics and antibiotics | Children with epididymitis / orchitis treated by analgetics and antibiotics. Receives: Other: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
No symptoms any more
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Mar 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epididymitis OrchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erez Nadir, MD, Hillel Yaffe Medical Center
- Investigators
- Erez Nadir, MD, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489979
- Sponsor's protocol ID
- 0012-20-HYMC
- Status last verified
- Aug 2021
- First submitted
- 29 Feb 2020
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 9158522
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgetics vs Analgetics and Antibiotics for Pediatric Clinical and Sonographic Orchitis or Epididymitis
- ClinicalTrials.gov ID
- NCT04489979
- Acronym / sponsor ID
- 0012-20-HYMC
- Conditions
- Epididymitis Orchitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analgetics only | – | Other: AntibioticsChildren with epididymitis / orchitis treated by analgetics only. |
| Analgetics and antibiotics | – | Other: AntibioticsChildren with epididymitis / orchitis treated by analgetics and antibiotics. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male children who were admitten to pediatric emergency department due to epididymitis or orchitis
Key inclusion criteria (1 listed)
- All children admitted to pediatric emergency department due to epididymitis or orchitis
Key exclusion criteria (5 listed)
- No sonographic or laboratory exam
- Antibiotic treatment before diagnosis
- No outpatient follow-up
- Known urologic congenital malformations
- Admission to inpatient department or emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsChildren with epididymitis / orchitis who were treated by antibiotics in addition to analgetics. | Other | Analgetics and antibiotics, Analgetics only |
Primary outcome
Healing
Time frame: 1 month
No symptoms any more
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Background: PubMed 9158522Lau 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erez Nadir, MD principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epididymitis Orchitis, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489979, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.