CClinicalTrials.gg
Status unknownNCT03688659Updated Sep 28, 2018

Vancomycin, Gentamycin in Infective Endocarditis

An interventional study of Vancomycin and gentamycin in Infective Endocarditis, sponsored by Assiut University. Status unknown. Open to participants aged 1 Week to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-28.

Sponsored by Assiut University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
1 Week to 18 Years
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Infective Endocarditis
03

In context

Endocarditis, Bacterial

85 studies on the registry are indexed under Endocarditis, Bacterial; 19 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 36 interventional studies indexed under Endocarditis, Bacterial.

Browse Endocarditis, Bacterial studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

Ages eligible
1 Week to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    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

Interventions

  • DrugVancomycin and gentamycin

    intravenous

    Also known as: vancomycin and geramycin

06

What researchers measure

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

    Time frame: 2 weeks

Secondary outcomes

  1. 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

    Time frame: 1 weeks

  2. 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

    Time frame: 4 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03688659
Lead sponsor
Assiut University
Responsible party
Sarah Sobhy Habib (principal investigator, Assiut University) — Principal investigator
First posted
Sep 28, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Jan 1, 2021 (estimated)
Completion
Jan 1, 2021 (estimated)
Last update
Sep 28, 2018

Study contacts

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

Oversight

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 Sep 2018. You cannot join it, but the record below documents what was studied.

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