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
About this trial
This is an interventional treatment trial for Infective Endocarditis
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
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
NCT ID
NCT03688659
First Posted
September 19, 2018
Last Updated
September 26, 2018
Sponsor
Assiut University
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
Learn more about this trial
Vancomycin, Gentamycin in Infective Endocarditis
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