Prosthetic Valve EndocarditisNCT05455788
Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?
An observational study of Prosthetic Valve Endocarditis, run by Assiut University at 1 site in Egypt.
Trial summary
Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prosthetic Valve Endocarditis
- What is being tested?
- Aminoglycoside
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 15 Dec 2023
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients diagnosed with heart valve disease and indicated for valve replacement.
Who may be able to join
- patients who need cardiac valve replacement for rheumatic or degenerative causes
Who cannot join
- Patients undergoing open heart surgery for any cause other than valve replacement
- patients who are younger than 20 years old.
- Patients undergoing valve repair.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 21557
Kareem A Hosny, 01000401994, kojakkemo@gmail.com
About this study
Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.
- Conditions
- Prosthetic Valve Endocarditis
- Being tested
- Aminoglycoside
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AminoglycosideDrug
injection of sewing ring of prosthetic valve with aminoglycoside
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing Cardiac valve replacement | Not described Receives: Drug: Aminoglycoside |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients diagnosed with Infective endocarditis post valve replacement
percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve
Measured: 6 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prosthetic Valve EndocarditisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Ibrahim Osman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455788
- Sponsor's protocol ID
- AssiutMedic
- Status last verified
- Jul 2022
- First submitted
- 1 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?
- ClinicalTrials.gov ID
- NCT05455788
- Acronym / sponsor ID
- AssiutMedic
- Conditions
- Prosthetic Valve Endocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Jul 2022 (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.
Follow-up of patients undergoing cardiac valve replacements with prosthetic valve after injection of sewing ring of prosthetic valve with aminoglycoside for prevention of infective endocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing Cardiac valve replacement | – | Drug: Aminoglycoside |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with heart valve disease and indicated for valve replacement.
Key inclusion criteria (1 listed)
- patients who need cardiac valve replacement for rheumatic or degenerative causes
Key exclusion criteria (3 listed)
- Patients undergoing open heart surgery for any cause other than valve replacement
- patients who are younger than 20 years old.
- Patients undergoing valve repair.
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 |
|---|---|---|
| Aminoglycosideinjection of sewing ring of prosthetic valve with aminoglycoside | Drug | Patients undergoing Cardiac valve replacement |
Primary outcome
number of patients diagnosed with Infective endocarditis post valve replacement
Time frame: 6 months post operative
percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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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.
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 Prosthetic Valve Endocarditis, run by Assiut University at 1 site in Egypt.
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 3 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 13 Jul 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kareem A Hosny (01000401994, kojakkemo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients diagnosed with Infective endocarditis post valve replacement (time frame: 6 months post operative). 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 13 Jul 2022.