NCT03688659

Brief Summary

Infective endocarditis is a microbial infection of the endocardial surface of the heart.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Status
unknown

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

September 19, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 19, 2018

Last Update Submit

September 26, 2018

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • vancomycin and gentamycin in infective endocarditis

    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by 1\. echocardiography to detect size of intracardiac vegetation

    2 weeks

Secondary Outcomes (2)

  • vancomycin and gentamycin in infective endocarditis

    1 weeks

  • vancomycin and gentamycin in infective endocarditis

    4 weeks

Study Arms (1)

vancomycin,gentamycin in endocarditis

OTHER

patients with infective endocarditis will recieve intravenous infusion Vancomycin 30 mg/kg/day for 4:6 weeks and intravenous Gentamycin 3mg/kg/day for 2 weeks

Drug: Vancomycin and gentamycin

Interventions

Vancomycin and gentamycinDRUG

intravenous

Also known as: vancomycin and geramycin
vancomycin,gentamycin in endocarditis

Eligibility Criteria

Age1 Week - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with cardiac proplem having infective endocaditis.
  • patients are newly diagnosed as recent intracardiac vegetations .

You may not qualify if:

  • patients are old diagnosed as intracardiac vegetations more than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endocarditis

Interventions

VancomycinGentamicins

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

GlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsAminoglycosidesGlycosides

Central Study Contacts

Fardous Hanem Abdelaal, professor

CONTACT

01003961323fardousabdelhafez@med.au.edu.eg

duaa mohamed raafat, assisstant professor

CONTACT

01223112124doaaahmed3@med.au.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
open
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 19, 2018

First Posted

September 28, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

September 28, 2018

Record last verified: 2018-09