The Incidence, Clinical Characteristics and Outcome of Infective Endocarditis Among Intravenous Drug Abusers Versus Non-Drug Abusers.

March 16, 2024 updated by: Peter Alaa Adeab Eskarous, Assiut University
We aim to describe the incidence of IVDA among patients presented with IE, describe their clinical, psychiatric and microbiological characteristics in comparison to non - IVDA, as well as the rate and types of complications and outcome, and responsiveness to medical treatment or surgical intervention.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Infective endocarditis (IE) is the infection of the endocardial surface of the heart mainly affecting the valves of the heart. It is still associated with very high morbidity and mortality all over the world despite various advances in diagnostic and treatment methods.

A few studies have shown that infective endocarditis represents less than 0.5% of adult cardiovascular admissions.While the overall incidence of IE has remained stable over the last several years, IE has increased in young people in parallel with injection drug use (IDU) behaviours and the growing opioid crisis.

According to recent guidelines , Intravenous (IV) drug use is considered a minor Duke criteria for the diagnosis of infective endocarditis.

Compared to the general population, intravenous drug abuse (IVDA) is associated with an up to 100-fold increased risk of IE through several mechanisms, including endothelial injury from injected particulate matter, direct injection of contaminated material, and drug-associated vasospasm leading to intimal damage and thrombus formation.

Also, IVDA is associated with HIV outbreaks, which is a well-known risk factor for IE. HIV-associated IE is associated with high rates of morbidity and mortality than non-HIV-associated IE.Because of its pathophysiology, IVDA-associated IE is more commonly right-sided. Beyond these known characteristics, however, literature on this topic is substantially limited, including the clinical and microbiological characteristics of these patients, rate and types of complications and outcomes.

Study Type

Observational

Enrollment (Estimated)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to Assiut University Heart Hospital with definite or possible Infective endocarditis

Description

Inclusion Criteria:

  • Adult Patients (>18 years) with definite or possible IE.

Exclusion Criteria:

  • Patients with rejected diagnosis of infective endocarditis after workup, according to modified Duke's criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
IE in IV drug abusers
Infective endocarditis in intravenous drug abusers
Diagnostic test: Echocardiography, Urine analysis , blood culture
All patients will be investigated by ECG, Urine analysis, blood culture , Echocardiography
IE in non- IV drug abusers
Infective endocarditis in non - intravenous drug abusers
Diagnostic test: Echocardiography, Urine analysis , blood culture
All patients will be investigated by ECG, Urine analysis, blood culture , Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of IVDA among IE patients
Time Frame: Baseline
Report the incidence of IVDA among IE patients, describe their clinical and microbiological characteristics comparison to the IE in non - IVDA.
Baseline
The complications of IVDA among IE patients
Time Frame: Baseline
Report the rates and types of complications
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The psychiatric characteristics of the addict group
Time Frame: Baseline

This will be done by psychiatric questionnaires:

-Addiction Severity Index questionnaire to measure severity of the addiction on the patient
Baseline
The Withdrawal symptoms of the study group
Time Frame: Baseline

This will be done by psychiatric questionnaires:

-Withdrawal symptoms questionnaire that occur to the patient after stop of the addiction
Baseline
The psychiatric characteristics of the study group
Time Frame: Baseline

This will be done by psychiatric questionnaires:

-Symptom Check List 90 to measure other comorbidities
Baseline
The personality characteristics of the study group
Time Frame: Baseline

This will be done by psychiatric questionnaires:

-Eysenck Personality questionnaire to measure personality.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Yehia Kish, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 5, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 2, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Infective endocarditis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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