Infective EndocarditisNCT03688659
Vancomycin, Gentamycin in Infective Endocarditis
A study testing Vancomycin and gentamycin in people with Infective Endocarditis, run by Assiut University.
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.
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
- Conditions
- Infective Endocarditis
- 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 group | Role | What they receive |
|---|---|---|
| vancomycin,gentamycin in endocarditis | Other | 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 Receives: Drug: Vancomycin and gentamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
vancomycin and gentamycin in infective endocarditis
using combination of intravenous vancomycin and intravenous gentamycin then assessment of patients by
- echocardiography to detect size of intracardiac vegetation
Measured: 2 weeks
Secondary outcomes (2)
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
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.
- First posted28 Sep 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Sobhy Habib, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Infective Endocarditis by Vancomycin and Gentamycin in Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT03688659
- Acronym / sponsor ID
- vgie
- Conditions
- Infective Endocarditis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vancomycin,gentamycin in endocarditis | Other | Drug: Vancomycin and gentamycinpatients 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 |
Who may qualify
- Ages
- 1 week to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients with cardiac proplem having infective endocaditis.
- patients are newly diagnosed as recent intracardiac vegetations .
Key exclusion criteria (1 listed)
- 1.patients are old diagnosed as intracardiac vegetations more than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vancomycin and gentamycinAlso: vancomycin and geramycinintravenous | Drug | vancomycin,gentamycin in endocarditis |
Primary outcome
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
2 secondary outcomes
vancomycin and gentamycin in infective endocarditis
Time frame: 1 weeks
vancomycin and gentamycin in infective endocarditis
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.