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

Primary Purpose

Endocarditis

Status
Enrolling by invitation
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Sponsored by
Vinay Badhwar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endocarditis focused on measuring Intravenous Drug Abuse Endocarditis, Oral Antibiotics, IV Antibiotics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • WVU Heart and Vascular Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (Experimental)

Group II (Control Group)

Arm Description

Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.

Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).

Outcomes

Primary Outcome Measures

To assess all-cause mortality at six (6) months post-surgery.
To assess all-cause mortality at six (6) months post-surgery.
To assess all-cause mortality at (12) months post-surgery.
To assess all-cause mortality at (12) months post-surgery.
To assess recurrent blood culture positive infection.
To assess recurrent blood culture positive infection.
To assess recurrent blood culture positive infection.
To assess recurrent blood culture positive infection.
To assess cardiac re-operation.
To assess cardiac re-operation.
To assess cardiac re-operation.
To assess cardiac re-operation.

Secondary Outcome Measures

Readmission for recurrent infection or cardiac re-operation
Readmission for recurrent infection or cardiac re-operation
Readmission for recurrent infection or cardiac re-operation
Readmission for recurrent infection or cardiac re-operation
Cost of care
Cost of care

Full Information

First Posted
November 16, 2021
Last Updated
October 27, 2022
Sponsor
Vinay Badhwar
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1. Study Identification

Unique Protocol Identification Number
NCT05156437
Brief Title
Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
Acronym
OPTIMAL
Official Title
Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Vinay Badhwar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis
Keywords
Intravenous Drug Abuse Endocarditis, Oral Antibiotics, IV Antibiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Postoperative patients who have undergone valvar repair or replacement for IVDA endocarditis will be randomized into two arms: Experimental: 2 weeks of postoperative inpatient IV antibiotic therapy followed by 4 weeks of oral therapy with outpatient follow-up; Control: conventional 2 weeks of postoperative inpatient IV antibiotic therapy followed by 4 weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized). Both groups will receive aggressive drug rehabilitation with mandatory participation in a formal psychiatric rehabilitation program for a minimum of 6 weeks (combined inpatient and outpatient), will be followed by Infectious Disease, will undergo monitoring of treatment efficacy with serum antibiotic levels, will undergo surveillance monitoring of treatment efficacy with blood cultures, will participate in a compliance tracking tool for medication administration (e.g. a centrally managed core site mobile Medisafe compliance program.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Experimental)
Arm Type
Experimental
Arm Description
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Arm Title
Group II (Control Group)
Arm Type
Active Comparator
Arm Description
Conventional two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of IV antibiotic therapy (inpatient or facility supervised if indwelling catheter utilized).
Intervention Type
Drug
Intervention Name(s)
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Intervention Description
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Intervention Type
Drug
Intervention Name(s)
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Intervention Description
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Primary Outcome Measure Information:
Title
To assess all-cause mortality at six (6) months post-surgery.
Description
To assess all-cause mortality at six (6) months post-surgery.
Time Frame
Six months
Title
To assess all-cause mortality at (12) months post-surgery.
Description
To assess all-cause mortality at (12) months post-surgery.
Time Frame
One year
Title
To assess recurrent blood culture positive infection.
Description
To assess recurrent blood culture positive infection.
Time Frame
Six months
Title
To assess recurrent blood culture positive infection.
Description
To assess recurrent blood culture positive infection.
Time Frame
One year
Title
To assess cardiac re-operation.
Description
To assess cardiac re-operation.
Time Frame
Six months
Title
To assess cardiac re-operation.
Description
To assess cardiac re-operation.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Readmission for recurrent infection or cardiac re-operation
Description
Readmission for recurrent infection or cardiac re-operation
Time Frame
Six months
Title
Readmission for recurrent infection or cardiac re-operation
Description
Readmission for recurrent infection or cardiac re-operation
Time Frame
One year
Title
Cost of care
Description
Cost of care
Time Frame
Through study completion, an average of one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vinay Badhwar, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
WVU Heart and Vascular Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30152252
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.
Results Reference
background
PubMed Identifier
32227127
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.
Results Reference
background
PubMed Identifier
32665381
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.
Results Reference
background
PubMed Identifier
32240296
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.
Results Reference
background
PubMed Identifier
30605448
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.
Results Reference
background
PubMed Identifier
27800528
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.
Results Reference
background
PubMed Identifier
26557487
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.
Results Reference
background
PubMed Identifier
27325495
Citation
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.
Results Reference
background
Links:
URL
https://www.cdc.gov/drugoverdose/deaths/index.html
Description
Centers for Disease Control and Prevention. Drug overdose Deaths
URL
http://wonder.cdc.gov
Description
Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (CDC WONDER): Multiple cause of death 1999-2017

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

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