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Vancomycin, Gentamycin in Infective Endocarditis

Primary Purpose

Infective Endocarditis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vancomycin and gentamycin
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infective Endocarditis

Eligibility Criteria

1 Week - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    vancomycin,gentamycin in endocarditis

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    vancomycin and gentamycin in infective endocarditis
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by compelete blood picture to detect leucocytosis
    vancomycin and gentamycin in infective endocarditis
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by CRP if >6 means positive results

    Full Information

    First Posted
    September 19, 2018
    Last Updated
    September 26, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03688659
    Brief Title
    Vancomycin, Gentamycin in Infective Endocarditis
    Official Title
    Treatment of Infective Endocarditis by Vancomycin and Gentamycin in Assiut University Children Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2021 (Anticipated)
    Study Completion Date
    January 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Infective endocarditis is a microbial infection of the endocardial surface of the heart.
    Detailed Description
    Infective endocarditis is usually suspected in a patient with fever and a new or changing cardiac murmur and is diagnosed based on the presence of a vegetation on echocardiography and positive blood cultures. Diagnosis of endocarditis is usually easy in febrile patients with a continuous bacteremia and the presence of vegetation on echocardiography Infective endocarditis includes bacterial endocarditis ( streptococcus viridans, enterococci and staphylococcus aureus are the main causes), as well as non bacterial endocarditis as those caused by viruses, fungi, chlamydia and rickettsia. It is usually superimposed on underlying congenital or rheumatic cardiac lesions, it also could occur in patients who had central vwnous catheter without underlying cardiac abnormality. Infective endocarditis has been clinically divided into acute and subacute presentation. Acute bacterial endocarditis is a fulminant illness over days to weeks (<2 weeks), and is more likely due to Staphylococcus aureus which has much greater virulence. Subacute bacterial endocarditis is often due to Streptococci of low virulence and mild to moderate illness which progresses slowly over weeks and months (>2 weeks). Bacterial endocarditis is a disease in which complete eradication of the organism is required. Bacteria involved in endocarditis are relatively protected from phagocytic activity by the vegetation, which contains high concentrations of bacteria with relatively low metabolic rates. Prolonged parenteral therapy is the only way to achieve bactericidal serum levels for the time needed to kill all the bacteria present in a vegetation of endocarditis. Treatment generally ranges from 4-8 weeks. Patient with native valve endocarditis caused by S.Pneumoniae may be given penicillin with or without aminoglycosides. combining an antistaphylococcal penicillin with an aminoglycoside covers against S.viridan,S.aureus and grame_negative organisms. vancomycin can be substituted for a semisynthetic penicillin if methecillin_resistant staphylococcus aureus infection or penicillin allergy is suspected vancomycin plus gentamycin for 4 weeks is recommended for those who are unable to tolerate B-lactam antibiotic agents,and is associated with faster clearing of bactereamia Investigation; positive blood culture leucocytosis elevated acute phase reactants like CRP, ESR anemia in long standing cases echocardiography Treatment hospitalization and bed rest treatment of heart failure using of anti coagulant therapy. antimicrobial agents: several general principles provide a basis for the treatment the choice of antimicrobial therapy depends on the organism and its sensetivity pattern parenteral therapy specially in infants and childern prolonged course usually 4-6weeks bactericidal agents synergetic combination: the usual initial regimens an antistaphlococcal semisynthetic penicillin and an aminoglycoside(Gentamycin),if a methicillin resistant S.aureus is suspected ,vancomycin should be substituted for the semisynthetic penicillin. vancomycin should be used in place of penicillin or semisynthetic penicillin in penicillin allergic patients vancomycin should be used in cases with echocardiographic signs of infective endocarditis in addition to gentamycin Surgical intervention; surgical debridment of infected material and replacement of the valve with a mechanical or bioprosthetic artificial heart valve is necessary in certain situations. patients with significant valve stenosis or regurgitation causing heart failure. recurrent septic emboli despite appropriate antibiotic treatment large vegetation (> 10 mm) abscess formation early closure of mitral valve

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infective Endocarditis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Masking Description
    open
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    vancomycin,gentamycin in endocarditis
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Vancomycin and gentamycin
    Other Intervention Name(s)
    vancomycin and geramycin
    Intervention Description
    intravenous
    Primary Outcome Measure Information:
    Title
    vancomycin and gentamycin in infective endocarditis
    Description
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by 1. echocardiography to detect size of intracardiac vegetation
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    vancomycin and gentamycin in infective endocarditis
    Description
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by compelete blood picture to detect leucocytosis
    Time Frame
    1 weeks
    Title
    vancomycin and gentamycin in infective endocarditis
    Description
    using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by CRP if >6 means positive results
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Week
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with cardiac proplem having infective endocaditis. patients are newly diagnosed as recent intracardiac vegetations . Exclusion Criteria: 1.patients are old diagnosed as intracardiac vegetations more than 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fardous Hanem Abdelaal, professor
    Phone
    01003961323
    Email
    fardousabdelhafez@med.au.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    duaa mohamed raafat, assisstant professor
    Phone
    01223112124
    Email
    doaaahmed3@med.au.edu.eg

    12. IPD Sharing Statement

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    Vancomycin, Gentamycin in Infective Endocarditis

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