Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)

Endocarditis Clinical Trial

— OPTIMAL  

Official title:

Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05156437
• Other study ID #: 2109416021
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 16, 2022
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and compliance of initial intravenous (IV) antibiotics followed by oral antibiotic therapy following uncomplicated IVDA endocarditis. Endocarditis has a high rate of sickness and death, involves a long hospitalization and a long-term use of IV antibiotics necessitating six (6) weeks of in-patient hospital stay, and comes with a high cost.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The age of the patient is = 18.
• The patient has undergone an urgent or emergent primary cardiac valvar operation as treatment for IVDA endocarditis, with blood cultures positive for Streptococcus, Enterococcus faecalis, Staphylococcus aureus, or coagulase-negative Staphylococci
• The patient has received 2 weeks of postoperative inpatient IV antibiotic therapy with negative blood cultures and no residual active infection by imaging (i.e. computerized axial tomography, echocardiography)
• The patient has the capacity to participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance https://www.medisafe.com/) as confirmed by both a physician and a care management team member

Exclusion Criteria:

• Inability to give informed consent
• Residual infection requiring IV antibiotic therapy
• Any persistent secondary noncardiac infection (e.g. infections of solid organs or joints)
• Known poor compliance or deemed incapable to comply with the compliance tracking tool
• Reduced absorption or inability to receive oral treatment due to a gastrointestinal disorder
• Any infection involving a more virulent organisms, such as fungal infections or infections with Serratia or HACEK infections (Haemophilus, Aggregatibacter, Cardiobacterium, Eikenella, Kingella).
• Cancer not otherwise in remission or in need of current or future oncologic therapy
• Medically immunocompromised state
• Reoperative valvar operation for IVDA endocarditis
• History of habitual noncompliance
• Pregnancy
• Mental incapacity
• Unable to perform local or institutional medical and psychiatric follow up
• Unstable home environment
• Inadequate access to mobile cell service (geographic/rurality)

Related Conditions & MeSH terms

• Endocarditis
• Substance Abuse, Intravenous
• Substance-Related Disorders

Intervention

Drug:
• Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
• Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Locations

Country	Name	City	State
United States	WVU Heart and Vascular Institute	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Vinay Badhwar

Country where clinical trial is conducted

United States, 

References & Publications (8)

Badhwar V, Wei LM, Rankin JS. Seeing the entire forest in endocarditis. J Thorac Cardiovasc Surg. 2016 Sep;152(3):681-2. doi: 10.1016/j.jtcvs.2016.05.050. Epub 2016 Jun 4. No abstract available. — View Citation

Brown E, Gould FK. Oral antibiotics for infective endocarditis: a clinical review. J Antimicrob Chemother. 2020 Aug 1;75(8):2021-2027. doi: 10.1093/jac/dkaa106. — View Citation

Iversen K, Ihlemann N, Gill SU, Madsen T, Elming H, Jensen KT, Bruun NE, Hofsten DE, Fursted K, Christensen JJ, Schultz M, Klein CF, Fosboll EL, Rosenvinge F, Schonheyder HC, Kober L, Torp-Pedersen C, Helweg-Larsen J, Tonder N, Moser C, Bundgaard H. Partial Oral versus Intravenous Antibiotic Treatment of Endocarditis. N Engl J Med. 2019 Jan 31;380(5):415-424. doi: 10.1056/NEJMoa1808312. Epub 2018 Aug 28. — View Citation

Kornbau C, Lee KC, Hughes GD, Firstenberg MS. Central line complications. Int J Crit Illn Inj Sci. 2015 Jul-Sep;5(3):170-8. doi: 10.4103/2229-5151.164940. — View Citation

Lemaignen A, Bernard L, Tattevin P, Bru JP, Duval X, Hoen B, Brunet-Houdard S, Mainardi JL, Caille A; RODEO (Relais Oral Dans le traitement des Endocardites a staphylocoques ou streptOcoques) and AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse) study groups. Oral switch versus standard intravenous antibiotic therapy in left-sided endocarditis due to susceptible staphylococci, streptococci or enterococci (RODEO): a protocol for two open-label randomised controlled trials. BMJ Open. 2020 Jul 14;10(7):e033540. doi: 10.1136/bmjopen-2019-033540. — View Citation

Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1. — View Citation

Spellberg B, Chambers HF, Musher DM, Walsh TL, Bayer AS. Evaluation of a Paradigm Shift From Intravenous Antibiotics to Oral Step-Down Therapy for the Treatment of Infective Endocarditis: A Narrative Review. JAMA Intern Med. 2020 May 1;180(5):769-777. doi: 10.1001/jamainternmed.2020.0555. — View Citation

Wurcel AG, Anderson JE, Chui KK, Skinner S, Knox TA, Snydman DR, Stopka TJ. Increasing Infectious Endocarditis Admissions Among Young People Who Inject Drugs. Open Forum Infect Dis. 2016 Jul 26;3(3):ofw157. doi: 10.1093/ofid/ofw157. eCollection 2016 Sep. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess all-cause mortality at six (6) months post-surgery.	To assess all-cause mortality at six (6) months post-surgery.	Six months
Primary	To assess all-cause mortality at (12) months post-surgery.	To assess all-cause mortality at (12) months post-surgery.	One year
Primary	To assess recurrent blood culture positive infection.	To assess recurrent blood culture positive infection.	Six months
Primary	To assess recurrent blood culture positive infection.	To assess recurrent blood culture positive infection.	One year
Primary	To assess cardiac re-operation.	To assess cardiac re-operation.	Six months
Primary	To assess cardiac re-operation.	To assess cardiac re-operation.	One year
Secondary	Readmission for recurrent infection or cardiac re-operation	Readmission for recurrent infection or cardiac re-operation	Six months
Secondary	Readmission for recurrent infection or cardiac re-operation	Readmission for recurrent infection or cardiac re-operation	One year
Secondary	Cost of care	Cost of care	Through study completion, an average of one year

External Links

•   Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (CDC WONDER): Multiple cause of death 1999-2017
•   Centers for Disease Control and Prevention. Drug overdose Deaths