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Vancomycin, Gentamycin in Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT03688659
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah Sobhy Habib, Assiut University

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

Condition or disease Intervention/treatment Phase
Infective Endocarditis Drug: Vancomycin and gentamycin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open
Primary Purpose: Treatment
Official Title: Treatment of Infective Endocarditis by Vancomycin and Gentamycin in Assiut University Children Hospital
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021


Arm Intervention/treatment
vancomycin,gentamycin in endocarditis
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
intravenous
Other Name: vancomycin and geramycin




Primary Outcome Measures :
  1. vancomycin and gentamycin in infective endocarditis [ Time Frame: 2 weeks ]

    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by

    1. echocardiography to detect size of intracardiac vegetation



Secondary Outcome Measures :
  1. vancomycin and gentamycin in infective endocarditis [ Time Frame: 1 weeks ]
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by compelete blood picture to detect leucocytosis

  2. vancomycin and gentamycin in infective endocarditis [ Time Frame: 4 weeks ]
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by CRP if >6 means positive results



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1.patients are old diagnosed as intracardiac vegetations more than 6 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688659


Contacts
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Contact: Fardous Hanem Abdelaal, professor 01003961323 fardousabdelhafez@med.au.edu.eg
Contact: duaa mohamed raafat, assisstant professor 01223112124 doaaahmed3@med.au.edu.eg

Sponsors and Collaborators
Assiut University

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Responsible Party: Sarah Sobhy Habib, principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03688659     History of Changes
Other Study ID Numbers: vgie
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vancomycin
Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action