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Infective EndocarditisNCT06194409

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

An observational study of Infective Endocarditis, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infective Endocarditis
What is being tested?
Echocardiography, Urine analysis , blood culture
Type of treatment
Injection or infusion
How many people
46 participants
Where
1 siteEgypt
Study dates
5 May 2024to Jun 2025
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 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Peter Alaa contact

01026654536

peteralaa391@gmail.com

Shimaa Sayed contact

+20 100 134 6551

shaimaakhidr@gmail.com

Egypt1 site, 1 recruiting

  • Assiut University

    Asyut

    Recruiting

Other trials in Egypt

About this study

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.

Being tested
Echocardiography, Urine analysis , blood culture
Medical subject headings
Endocarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Echocardiography, Urine analysis , blood cultureDiagnostic test

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

Study groups in NCT06194409
Study groupRoleWhat they receive
IE in IV drug abusersInfective endocarditis in intravenous drug abusers
Receives: Diagnostic Test: Echocardiography, Urine analysis , blood culture
IE in non- IV drug abusersInfective endocarditis in non - intravenous drug abusers
Receives: Diagnostic Test: Echocardiography, Urine analysis , blood culture

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

  2. The complications of IVDA among IE patients

    Report the rates and types of complications

    Measured: Baseline

Secondary outcomes (4)

  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

    Measured: 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

    Measured: Baseline

  3. The psychiatric characteristics of the study group

    This will be done by psychiatric questionnaires:

    -Symptom Check List 90 to measure other comorbidities

    Measured: Baseline

  4. The personality characteristics of the study group

    This will be done by psychiatric questionnaires:

    -Eysenck Personality questionnaire to measure personality.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2024
  2. Study start5 May 2024
  3. Primary completionMay 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

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
Cross-sectional
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06194409
Sponsor's protocol ID
Infective endocarditis
Status last verified
Jun 2024
First submitted
2 Oct 2023
Last updated
25 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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]

Questions about this trial

What is this clinical trial studying?

An observational study of Infective Endocarditis, run by Assiut University at 1 site in Egypt.

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 1 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Peter Alaa (01026654536, peteralaa391@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of IVDA among IE patients (time frame: Baseline). 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?

On the ClinicalTrials.gov record for NCT06194409, which also lists 11 linked publications.

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 25 Jun 2024.

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