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

NCT ID: NCT05156437

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Endocarditis

Keywords

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Intravenous Drug Abuse Endocarditis Oral Antibiotics IV Antibiotics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group I (Experimental)

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

Group Type EXPERIMENTAL

Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Intervention Type DRUG

Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Intervention Type DRUG

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Group II (Control Group)

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).

Group Type ACTIVE_COMPARATOR

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Intervention Type DRUG

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Interventions

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Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin

Intervention Type DRUG

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vinay Badhwar

OTHER

Sponsor Role lead

Responsible Party

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Vinay Badhwar

Executive Chair, Heart & Vascular Institute

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vinay Badhwar, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

Locations

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WVU Heart and Vascular Institute

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30152252 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32227127 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32665381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32240296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30605448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27800528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26557487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27325495 (View on PubMed)

Related Links

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http://wonder.cdc.gov

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

Other Identifiers

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2109416021

Identifier Type: -

Identifier Source: org_study_id