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.
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.
- Conditions
- Infective Endocarditis
- 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.
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.
- First posted4 Apr 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion30 Dec 2019 (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.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Safaa Samir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Safaa Samir, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of the Most Common Micro Organism of Infective Endocarditis in Assiut University Hospital
- ClinicalTrials.gov ID
- NCT03487653
- Acronym / sponsor ID
- Assiut university hosbital
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Safaa SamirUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 4 Apr 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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Detection of the most common organism of infective endocarditis
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 |
|---|---|---|
| microbiology:Blood culture and sensitvity test .SerologyGram stain ,Blood culture ,sensitivity test ,biochemical reactions and serological study will be done | Biological | – |
Primary outcome
Detection of the most common micro organism of infective endocarditis
Time frame: 2years
Detection of the most common microorganism of infective endocarditis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: Undecided
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CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.