Infective EndocarditisCRP-IENCT02466139
Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis
An observational study of Infective Endocarditis, run by Government Medical College, Kozhikode.
Trial summary
The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infective Endocarditis
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Apr 2015
- How long will I take part?
- 6 Months
- 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: Consecutive patients with infective endocarditis treated in a tertiary care centre
Who may be able to join
- Fulfillment of modified Duke criteria
Who cannot join
- No consent
- inadequate baseline data
About this study
Official title: Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes Among Infective Endocaridtis Patients in a Tertiary-care Centre in Kerala
The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.
Read the detailed description
Mortality and major complications among infective endocarditis remain high. In addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. We intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.
- Conditions
- Infective Endocarditis
- Keywords
- microbiology, c reactive protein, urgent cardiac surgery
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Measured: 30 days
Major complications
Measured: 30 days
Secondary outcomes (3)
Number of patients who had embolic events
Measured: 30 days
Number of patients who needed urgent cardiac surgery
Measured: 30 days
Short term Mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startApr 2012
- Primary completionApr 2015
- Study completionApr 2015
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Government Medical College, Kozhikode
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandeep Mohanan, Government Medical College, Kozhikode
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02466139
- Sponsor's protocol ID
- IEregister2012-2015
- Acronym
- CRP-IE
- Status last verified
- Jun 2015
- First submitted
- 2 Jun 2015
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes Among Infective Endocaridtis Patients in a Tertiary-care Centre in Kerala
- ClinicalTrials.gov ID
- NCT02466139
- Acronym / sponsor ID
- CRP-IE / IEregister2012-2015
- Conditions
- Infective Endocarditis
- Keywords
- microbiology, c reactive protein, urgent cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Government Medical College, KozhikodeUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- 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.
The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.
Detailed description
Mortality and major complications among infective endocarditis remain high. In addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. We intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients with infective endocarditis treated in a tertiary care centre
Key inclusion criteria (1 listed)
- Fulfillment of modified Duke criteria
Key exclusion criteria (2 listed)
- No consent
- inadequate baseline data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital mortality
Time frame: 30 days
Major complications
Time frame: 30 days
3 secondary outcomes
Number of patients who had embolic events
Time frame: 30 days
Number of patients who needed urgent cardiac surgery
Time frame: 30 days
Short term Mortality
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
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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 Government Medical College, Kozhikode.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 9 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In-hospital mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 9 Jun 2015.