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

Infective Endocarditis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06194409
• Other study ID #: Infective endocarditis
• Status: Not yet recruiting
• Start date: May 5, 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Assiut University
• Contact: Peter Alaa
• Phone: 01026654536
• Email: peteralaa391[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

Diagnostic Test:
• Echocardiography, Urine analysis , blood culture
All patients will be investigated by ECG, Urine analysis, blood culture , Echocardiography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (11)

Bor DH, Woolhandler S, Nardin R, Brusch J, Himmelstein DU. Infective endocarditis in the U.S., 1998-2009: a nationwide study. PLoS One. 2013;8(3):e60033. doi: 10.1371/journal.pone.0060033. Epub 2013 Mar 20. — View Citation

Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available. Erratum In: Eur Heart J. 2023 Sep 20;: Eur Heart J. 2024 Jan 1;45(1):56. — View Citation

Derogatis, L.R. and Savitz, K.L. (2000) The SCL-90-R and the Brief Symptom Inventory (BSI) in Primary Care. In:: Maruish, M.E., Ed., Handbook of Psychological Assessment in Primary Care Settings, Vol. 236, Lawrence Erlbaum Associates, Mahwah, 297-334

Goyal A, Mohan B, Kumar P, Gupta D, Tandon R, Singla S, Singh G, Singh B, Chhabra ST, Aslam N, Wander GS. Clinical characteristics and outcome of infective endocarditis among intravenous drug abusers in India. Indian Heart J. 2020 Nov-Dec;72(6):547-551. doi: 10.1016/j.ihj.2020.09.014. Epub 2020 Sep 18. — View Citation

Hans Jürgen Eysenck & Sybil B. G. Eysenck (1975). Manual of the Eysenck Personality Questionnaire, London: Hodder and Stoughton

Macingwane J., Ngwenya B.N. Identification of active compounds of Albizia lebbeck against HIV-1 reverse transcriptase: a computational study. J. Biomol. Struct. Dyn. 2021;39(14):5300-5311. [Google Scholar]

Math RS, Sharma G, Kothari SS, Kalaivani M, Saxena A, Kumar AS, Bahl VK. Prospective study of infective endocarditis from a developing country. Am Heart J. 2011 Oct;162(4):633-8. doi: 10.1016/j.ahj.2011.07.014. Epub 2011 Sep 14. — View Citation

McLellan AT, Luborsky L, Woody GE, O'Brien CP. An improved diagnostic evaluation instrument for substance abuse patients. The Addiction Severity Index. J Nerv Ment Dis. 1980 Jan;168(1):26-33. doi: 10.1097/00005053-198001000-00006. — View Citation

Noubiap JJ, Nkeck JR, Kwondom BS, Nyaga UF. Epidemiology of infective endocarditis in Africa: a systematic review and meta-analysis. Lancet Glob Health. 2022 Jan;10(1):e77-e86. doi: 10.1016/S2214-109X(21)00400-9. — View Citation

Scheggi V, Del Pace S, Ceschia N, Vanni F, Merilli I, Sottili E, Salcuni L, Zoppetti N, Alterini B, Cerillo A, Marchionni N, Stefano PL. Infective endocarditis in intravenous drug abusers: clinical challenges emerging from a single-centre experience. BMC Infect Dis. 2021 Sep 27;21(1):1010. doi: 10.1186/s12879-021-06697-1. — View Citation

Schranz AJ, Fleischauer A, Chu VH, Wu LT, Rosen DL. Trends in Drug Use-Associated Infective Endocarditis and Heart Valve Surgery, 2007 to 2017: A Study of Statewide Discharge Data. Ann Intern Med. 2019 Jan 1;170(1):31-40. doi: 10.7326/M18-2124. Epub 2018 Dec 4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of IVDA among IE patients	Report the incidence of IVDA among IE patients, describe their clinical and microbiological characteristics comparison to the IE in non - IVDA.	Baseline
Primary	The complications of IVDA among IE patients	Report the rates and types of complications	Baseline
Secondary	The psychiatric characteristics of the addict group	This will be done by psychiatric questionnaires: -Addiction Severity Index questionnaire to measure severity of the addiction on the patient	Baseline
Secondary	The Withdrawal symptoms of the study group	This will be done by psychiatric questionnaires: -Withdrawal symptoms questionnaire that occur to the patient after stop of the addiction	Baseline
Secondary	The psychiatric characteristics of the study group	This will be done by psychiatric questionnaires: -Symptom Check List 90 to measure other comorbidities	Baseline
Secondary	The personality characteristics of the study group	This will be done by psychiatric questionnaires: -Eysenck Personality questionnaire to measure personality.	Baseline