Ear Infection BacterialPhase 4NCT04707092
Use of Preoperative and Postoperative Antimicrobial Treatment
A Phase 4 study testing Antibiotic in people with Ear Infection Bacterial and Surgical Site Infection, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups. One group will receive a single treatment with an antibiotic at induction The other group will receive the single intravenous treatment, plus a one week… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ear Infection Bacterial, Surgical Site Infection, Antibiotic Side Effect
- What is being tested?
- Antibiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 31 Dec 2022
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study
- Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)
Who cannot join
- multiple allergies to antibiotic substances
- therapy with an antibiotic substance within the last 6 weeks
- prior radiation to the head and neck patients undergoing revision surgery
- Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection
Trial locations and contacts
1 site in 1 country.
About this study
In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.
One group will receive a single treatment with an antibiotic at induction
The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic
Read the detailed description
- Patients will be asked to participate in the study.
- Randomization
- Surgery
- Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation
- Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections
- Being tested
- Antibiotic
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticDrug
Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic at induction | Experimental | Patients will receive one single dose of Antibiotic at induction Receives: Drug: Antibiotic |
| Antibiotic one week | Experimental | Patients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Side effects from treatment with antibiotics
Measured: 1 month
Secondary outcomes (2)
Infection of surgical site (immediate)
Infection of surgical site with discharge, redness, fever
Measured: 1 month
Infection of surgical site (long term)
infection of surgical site with discharge, fever, extrusion of device
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear Infection BacterialStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in two treatment arms
- Masking
- None (open label)
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707092
- Sponsor's protocol ID
- 3486
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared since no conclusions can be drawn from single patient data, the results will be made available in detail
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Preoperative and Postoperative Antimicrobial Treatment
- ClinicalTrials.gov ID
- NCT04707092
- Acronym / sponsor ID
- 3486
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Jan 2021 (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.
In this study, patients undergoing ear surgery (cochlear implantation, stapedotomy, tympanoplasty) will be randomized to one of two antibiotic treatment groups.
One group will receive a single treatment with an antibiotic at induction
The other group will receive the single intravenous treatment, plus a one week course or oral antibiotic
Detailed description
- Patients will be asked to participate in the study.
- Randomization
- Surgery
- Follow-up at 1 week, 1 month patients will be asked if they filled their prescription, took the medication as prescribed, experienced any symptoms such as rash, diarrhea, nausea,.. Further the wound will be inspected for any signs of infection. Patients will also be asked if they had noticed discharge, pain, pulsating sensation
- Follow-up at three months, 1 year and 2 years - patients will again be asked for any signs of infections or necessary visits with their doctor due to infections
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization in two treatment arms
| Arm | Type | Receives |
|---|---|---|
| Antibiotic at induction | Experimental | Drug: AntibioticPatients will receive one single dose of Antibiotic at induction |
| Antibiotic one week | Experimental | Drug: AntibioticPatients will receive one single dose of Antibiotic at induction, plus a 7 day treatment with oral Antibiotic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to participate in the study
- Undergoing standard ear surgery (Stapedotomy, cochlear implantation, tympanoplasty and tympanomastoidectomy)
Key exclusion criteria (4 listed)
- multiple allergies to antibiotic substances
- therapy with an antibiotic substance within the last 6 weeks
- prior radiation to the head and neck patients undergoing revision surgery
- Any use of post-operative antibiotics (oral, intravenous, topical) for reason which do not include surgical site infection
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 |
|---|---|---|
| AntibioticAntibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week | Drug | Antibiotic at induction, Antibiotic one week |
Primary outcome
Adverse events
Time frame: 1 month
Side effects from treatment with antibiotics
2 secondary outcomes
Infection of surgical site (immediate)
Time frame: 1 month
Infection of surgical site (long term)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: No. The individual participant data will not be shared since no conclusions can be drawn from single patient data, the results will be made available in detail
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotic in people with Ear Infection Bacterial and Surgical Site Infection, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Oct 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Adverse events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2021.