Not provided
Not provided
Not provided
Not provided
The study was stopped because all five participants were lost to follow-up before completing treatment or any assessments, leaving no outcome data available and making continuation of the trial infeasible.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Experimental) | Experimental | Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. |
|
| Group II (Control Group) | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin | Drug | Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality at Six (6) Months Post-surgery. | Incidences of all-cause mortality at six (6) months post-surgery. | Six months |
| All-cause Mortality at (12) Months Post-surgery. | Incidences of all-cause mortality at (12) months post-surgery. | One year |
| Incidence of Recurrent Blood Culture Positive Infection (6 Month) | Incidence of recurrent blood culture positive infection (6 month) | Six months |
| Incidence of Recurrent Blood Culture Positive Infection (1 Year) | Incidence of recurrent blood culture positive infection (1 year) | One year |
| Incidence of Cardiac Re-operation (6 Month) | Incidence of cardiac re-operation (6 Month) | Six months |
| Incidence of Cardiac Re-operation (1 Year) | Incidence of cardiac re-operation (1 Year) | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Readmission for Recurrent Infection or Cardiac Re-operation (6 Month) | Incidences of readmission for recurrent infection or cardiac re-operation (6 Month) | Six months |
| Readmission for Recurrent Infection or Cardiac Re-operation (1 Year) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vinay Badhwar, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WVU Heart and Vascular Institute | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30152252 | Background | 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. | |
| 32227127 |
| Label | URL |
|---|---|
| Centers for Disease Control and Prevention Wide-ranging Online Data for Epidemiologic Research (CDC WONDER): Multiple cause of death 1999-2017 | View source |
Not provided
Five participants were enrolled and assigned to two study arms (Group I: 4; Group II: 1). After surgery and treatment initiation, all were lost to follow-up before completing the six-week therapy period or reaching any follow-up visit, resulting in 0 completions. The only reason for non-completion was loss to follow-up; no participants withdrew consent, had adverse events, or were removed. All were classified as "Not Completed-Lost to Follow-up."
Participants were recruited from a population with substance use disorder and active or recent infective endocarditis requiring surgery. Recruitment and retention were difficult due to social instability, limited outpatient engagement, and challenges maintaining contact. Five participants enrolled, but all were lost to follow-up before completing therapy or reaching the first assessment, and no additional eligible participants could be retained.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Experimental) | Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2023 |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline | Drug | Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline |
|
Incidence of readmission for recurrent infection or cardiac re-operation (1 Year)
| One year |
| Cost of Care | Cost of care | Through study completion, an average of one year |
| Background |
| 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. |
| 32665381 | Background | 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. |
| 32240296 | Background | 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. |
| 30605448 | Background | 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. |
| 27800528 | Background | 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. |
| 26557487 | Background | 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. |
| 27325495 | Background | 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. |
| FG001 | 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). Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Experimental) | Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. 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 |
| BG001 | 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). Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality at Six (6) Months Post-surgery. | Incidences of all-cause mortality at six (6) months post-surgery. | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | Six months |
|
| ||||||||||||||||||||||
| Primary | All-cause Mortality at (12) Months Post-surgery. | Incidences of all-cause mortality at (12) months post-surgery. | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | One year |
| |||||||||||||||||||||||
| Primary | Incidence of Recurrent Blood Culture Positive Infection (6 Month) | Incidence of recurrent blood culture positive infection (6 month) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | Six months |
| |||||||||||||||||||||||
| Primary | Incidence of Recurrent Blood Culture Positive Infection (1 Year) | Incidence of recurrent blood culture positive infection (1 year) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | One year |
| |||||||||||||||||||||||
| Primary | Incidence of Cardiac Re-operation (6 Month) | Incidence of cardiac re-operation (6 Month) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | Six months |
| |||||||||||||||||||||||
| Primary | Incidence of Cardiac Re-operation (1 Year) | Incidence of cardiac re-operation (1 Year) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | One year |
| |||||||||||||||||||||||
| Secondary | Readmission for Recurrent Infection or Cardiac Re-operation (6 Month) | Incidences of readmission for recurrent infection or cardiac re-operation (6 Month) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the six-month assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | Six months |
| |||||||||||||||||||||||
| Secondary | Readmission for Recurrent Infection or Cardiac Re-operation (1 Year) | Incidence of readmission for recurrent infection or cardiac re-operation (1 Year) | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to the one-year assessment. As a result, no outcome data were collected for this measure in either arm, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | One year |
| |||||||||||||||||||||||
| Secondary | Cost of Care | Cost of care | All participants enrolled in the study were assigned to a study arm; however, all participants were lost to follow-up prior to study completion. Because no participants completed the study, no cost of care data were collected, and no participants were included in the analysis population. No interim, partial, or alternative data were available for analysis. | Posted | Through study completion, an average of one year |
|
No adverse events were collected, monitored or assessed at any time during the study.
No adverse event data were collected. All enrolled participants were lost to follow-up prior to completing treatment or any assessment. As a result, adverse events (including all-cause mortality, serious adverse events, and other adverse events) were not monitored or assessed, and the number of participants at risk in each arm is 0.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Experimental) | Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up. 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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). Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
This study had complete loss to follow-up for all enrolled participants (N=5), a vulnerable population with high instability due to substance use disorder. No participant completed treatment or any follow-up visit, so no outcome data were collected and no endpoints could be evaluated. The small sample and lack of data prevent statistical analysis and limit study conclusions.
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vinay Badhwar | West Virginia University | 304-598-4151 | vinay.badhwar@wvumedicine.org |
| Aug 25, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2021 | Aug 25, 2025 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D004696 | Endocarditis |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D002506 | Cephalexin |
| D004009 | Dicloxacillin |
| D000069349 | Linezolid |
| D064704 | Levofloxacin |
| D012293 | Rifampin |
| D000667 | Ampicillin |
| D010068 | Oxacillin |
| D014640 | Vancomycin |
| D017576 | Daptomycin |
| D002443 | Ceftriaxone |
| D000077723 | Cefepime |
| D000097583 | Ceftaroline |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D003023 | Cloxacillin |
| D000081 | Acetamides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|