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Infective EndocarditisNCT03487653

Detection of the Most Common Microorganism of Infective Endocarditis in Assiut University Hospital

An observational study of Infective Endocarditis, run by Safaa Samir.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Indocarditis is an endogenous infection acquired when organisms entering the blood stream establish on the heart valves, therefore, any bacteremia can potentially result in endocarditis. Infective endocarditis is an uncommon disease that often presents as pyrexia of unknown origin. Read more about this study

Who is it for?
Any age
Conditions the study is for
Infective Endocarditis
What is being tested?
microbiology:Blood culture and sensitvity test .Serology
How many people
50 participants
Where
No sites listed yet
Study dates
1 Dec 2018to 30 Dec 2019
Phase
Observational
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Detection of the most common organism of infective endocarditis

Inclusion Criteria:patients that are clinically diagnosed as infective endocarditis before starting antibiotics

Exclusion Criteria:patients that receive antibiotics before taking the blood sample

About this study

Official title: Detection of the Most Common Micro Organism of Infective Endocarditis in Assiut University Hospital

Indocarditis is an endogenous infection acquired when organisms entering the blood

stream establish on the heart valves, therefore, any bacteremia can potentially result in endocarditis.

Read more

Infective endocarditis is an uncommon disease that often presents as pyrexia of unknown origin.

The mortality rate in endocarditis was very high before the antibiotic era, even now a day, the

mortality rate is around 20%(1).A variety of microorganisms can cause IE; staphylococci and streptococci account for the majority of cases. Staphylococcal IE is a common cause of healthcare-associated IE ; streptococcal IE is a common cause of community-acquired IE. Common bacterial pathogens include Staphylococcus aureus , Viridans group streptococci , Enterococcus, Coagulase-negative staphylococci , Streptococcus bovis , other streptococci , gram-negative bacteria, HACEK organisms in this category include a number of fastidious gram-negative bacilli: Haemophilus aphrophilus(subsequently called Aggregatibacter aphrophilus and Aggregatibacter paraphrophilus); Actinobacillus actinomycetemcomitans (subsequently called Aggregatibacter actinomycetemcomitans); Cardiobacterium hominis; Eikenella corrodens; and Kingella kingae , and fungi (1,2). A variable proportion of IE remain blood culture- negative (1-4). Most clinically significant bacteremias are detected within 48 hours; common and fastidious pathogens (such as members of the HACEK group) may be detected within five days of incubation with modern automated blood culture detection systems. The optimal volume of blood for each blood culture in adults is 20 ml.

Zoonotic agents, such as Coxiella burnetii, Brucella spp., and Bartonella spp. were frequently detected in North Africa and identified as causes of infective endocarditis (IE) in Egypt (3,4).Blood culture is the most important investigation for diagnosing infective endocarditis

andto know the prevalence rate of different bacteria and their antibiotic sensitivity pattern.Positive blood culture is the cornerstone of microbiological diagnosis of IE; three sets of blood cultures detect 96 to 98 percent of bacteremia. At least three sets of blood cultures should be obtained from separate venipuncture sites prior to initiation of antibiotic therapy. Patients with IE typically have continuous bacteremia; therefore, blood cultures may be collected at any time and need not necessarily be obtained at the time of fever or chills.

MATERIAL and METHOD A total of 150 blood cultures were received from 50 clinically diagnosed cases of bacterial endocarditis .

Blood sample was collected under all aseptic precautions.

Being tested
microbiology:Blood culture and sensitvity test .Serology
Medical subject headings
Endocarditis

What participants receive

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

  • microbiology:Blood culture and sensitvity test .SerologyBiological

    Gram stain ,Blood culture ,sensitivity test ,biochemical reactions and serological study will be done

What is being measured

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

  1. Detection of the most common micro organism of infective endocarditis

    Detection of the most common microorganism of infective endocarditis

    Measured: 2years

Timeline

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

  1. First posted4 Apr 2018
  2. Study start1 Dec 2018 (estimated)
  3. Primary completion1 Mar 2019 (estimated)
  4. Study completion30 Dec 2019 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03487653
Sponsor's protocol ID
Assiut university hosbital
Status last verified
Mar 2018
First submitted
1 Mar 2018
Last updated
6 Jul 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Infective Endocarditis, run by Safaa Samir.

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

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of the most common micro organism of infective endocarditis (time frame: 2years). 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 6 Jul 2018.

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