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Status unknownNCT06194409Updated Jun 25, 2024

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

An observational study in Infective Endocarditis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
46
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Infective Endocarditis

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In context

Endocarditis

174 studies on the registry are indexed under Endocarditis; 52 are open to participants now.

This study's planned enrollment of 46 is below the median of 256 across 84 observational studies indexed under Endocarditis.

Browse Endocarditis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
46 participants (estimated)
Patient registry
No

Groups and cohorts

  • IE in IV drug abusers

    Infective endocarditis in intravenous drug abusers

    Diagnostic Test: Echocardiography, Urine analysis , blood culture

  • IE in non- IV drug abusers

    Infective endocarditis in non - intravenous drug abusers

    Diagnostic Test: Echocardiography, Urine analysis , blood culture

Interventions

  • Diagnostic testEchocardiography, Urine analysis , blood culture

    All patients will be investigated by ECG, Urine analysis, blood culture , Echocardiography

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

  2. The complications of IVDA among IE patients

    Report the rates and types of complications

    Time frame: Baseline

Secondary outcomes

  1. 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

    Time frame: Baseline

  2. 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

    Time frame: Baseline

  3. The psychiatric characteristics of the study group

    This will be done by psychiatric questionnaires: -Symptom Check List 90 to measure other comorbidities

    Time frame: Baseline

  4. The personality characteristics of the study group

    This will be done by psychiatric questionnaires: -Eysenck Personality questionnaire to measure personality.

    Time frame: Baseline

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Study locations

1 of 1 sites recruiting
  • Assiut University
    Asyut, Egypt
    Recruiting
08

References and documents

Publications

  • 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. PubMed 21982654 ↗
  • 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. PubMed 34919859 ↗
  • 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. PubMed 23527296 ↗
  • 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. PubMed 30508432 ↗
  • 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. PubMed 37622656 ↗
  • 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. PubMed 34579674 ↗
  • 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. PubMed 33357643 ↗
  • 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. PubMed 7351540 ↗
  • 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
  • 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]
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06194409
Lead sponsor
Assiut University
Responsible party
Peter Alaa Adeab Eskarous (Resident at cardiology department, Faculty of medicine, Assiut University, Assiut University) — Principal investigator
First posted
Jan 8, 2024
Start date
May 5, 2024
Primary completion
May 2025 (estimated)
Completion
Jun 2025 (estimated)
Last update
Jun 25, 2024

Study contacts

Peter Alaa
Contact
peteralaa391@gmail.com
01026654536
Shimaa Sayed
Contact
shaimaakhidr@gmail.com
+20 100 134 6551
Yehia Kish
study director · Assiut University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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