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Status unknownNCT05455788Updated Jul 13, 2022

Prosthetic Valve Sweing Ring Injection by Antiboitics Can Affect the Rate of Postoperative Infective Endocarditis?

An observational study in Prosthetic Valve Endocarditis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-13.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Prosthetic Valve Endocarditis

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's planned enrollment of 300 is above the median of 225 across 82 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Assiut University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients diagnosed with heart valve disease and indicated for valve replacement.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients who need cardiac valve replacement for rheumatic or degenerative causes

Exclusion criteria

Exclusion Criteria:

  • Patients undergoing open heart surgery for any cause other than valve replacement
  • patients who are younger than 20 years old.
  • Patients undergoing valve repair.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients undergoing Cardiac valve replacement

    Drug: Aminoglycoside

Interventions

  • DrugAminoglycoside

    injection of sewing ring of prosthetic valve with aminoglycoside

06

What researchers measure

Primary outcomes

  1. number of patients diagnosed with Infective endocarditis post valve replacement

    percentage of post operative clinical and echocardiographic diagnosis of infective endocarditis on prosthetic valve

    Time frame: 6 months post operative

07

Study locations

1 of 1 sites recruiting
  • Assiut University
    Assiut, 21557, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2021 (actual). Primary completion is estimated for Dec 2023, 24 months after the start.

Of 36 observational studies under Endocarditis, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 36. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2022
First posted
Jul 13, 2022
StartActual
Dec 1, 2021
Primary completionEst.
Dec 1, 2023
CompletionEst.
Dec 15, 2023
Last update
Jul 13, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05455788
Lead sponsor
Assiut University
Responsible party
Amr Ibrahim Osman (Principle investigator, Assiut University) — Principal investigator
First posted
Jul 13, 2022
Start date
Dec 1, 2021
Primary completion
Dec 1, 2023 (estimated)
Completion
Dec 15, 2023 (estimated)
Last update
Jul 13, 2022

Study contacts

Kareem A Hosny
Contact
kojakkemo@gmail.com
01000401994
Amr I Osman
Contact
dr.amr-osman@outlook.com
01000433878

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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