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Infective EndocarditisNCT03688659

Vancomycin, Gentamycin in Infective Endocarditis

A study testing Vancomycin and gentamycin in people with Infective Endocarditis, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Infective endocarditis is a microbial infection of the endocardial surface of the heart. Read more about this study

Who is it for?
Ages 1 week to 18 years
Conditions the study is for
Infective Endocarditis
What is being tested?
Vancomycin and gentamycin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
1 Jan 2019to 1 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 week to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Fardous Hanem Abdelaal, professor contact

01003961323

fardousabdelhafez@med.au.edu.eg

duaa mohamed raafat, assisstant professor contact

01223112124

doaaahmed3@med.au.edu.eg

About this study

Official title: Treatment of Infective Endocarditis by Vancomycin and Gentamycin in Assiut University Children Hospital

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
Being tested
Vancomycin and gentamycin
Medical subject headings
Endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vancomycin and gentamycinDrug

    Also called vancomycin and geramycin

    intravenous

Study groups in NCT03688659
Study groupRoleWhat they receive
vancomycin,gentamycin in endocarditisOtherpatients 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
Receives: Drug: Vancomycin and gentamycin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 weeks

Secondary outcomes (2)
  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

    Measured: 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

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2018
  2. Study start1 Jan 2019 (estimated)
  3. Primary completion1 Jan 2021 (estimated)
  4. Study completion1 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03688659
Sponsor's protocol ID
vgie
Status last verified
Sep 2018
First submitted
19 Sep 2018
Last updated
28 Sep 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Vancomycin and gentamycin in people with Infective Endocarditis, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Fardous Hanem Abdelaal, professor (01003961323, fardousabdelhafez@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

vancomycin and gentamycin in infective endocarditis (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.

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