EndocarditisPhase 4OPTIMALNCT05156437

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

A Phase 4 study testing Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin and Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline in people with Endocarditis, run by West Virginia University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Endocarditis
What is being tested?: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin and Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2022to 31 Oct 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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).

Show all 15Show fewer

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)

Trial locations and contacts

1 site in 1 country.

United States1 site

WVU Heart and Vascular Institute
Morgantown, West Virginia, 26506

Other trials in United States

About this study

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.

Conditions: Endocarditis
Being tested: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin, Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
Keywords: Intravenous Drug Abuse Endocarditis, Oral Antibiotics, IV Antibiotics
Medical subject headings: Endocarditis

What participants receive

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

Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, RifampicinDrug
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, CeftarolineDrug
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

Study groups in NCT05156437
Study group	Role	What they receive
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. Receives: Drug: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin; Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline
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). Receives: Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline

What is being measured

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

All-cause Mortality at Six (6) Months Post-surgery.
Incidences of all-cause mortality at six (6) months post-surgery.
Measured: Six months
All-cause Mortality at (12) Months Post-surgery.
Incidences of all-cause mortality at (12) months post-surgery.
Measured: One year
Incidence of Recurrent Blood Culture Positive Infection (6 Month)
Incidence of recurrent blood culture positive infection (6 month)
Measured: Six months
Incidence of Recurrent Blood Culture Positive Infection (1 Year)
Incidence of recurrent blood culture positive infection (1 year)
Measured: One year
Incidence of Cardiac Re-operation (6 Month)
Incidence of cardiac re-operation (6 Month)
Measured: Six months
Incidence of Cardiac Re-operation (1 Year)
Incidence of cardiac re-operation (1 Year)
Measured: One year

Secondary outcomes (3)

Readmission for Recurrent Infection or Cardiac Re-operation (6 Month)
Incidences of readmission for recurrent infection or cardiac re-operation (6 Month)
Measured: Six months
Readmission for Recurrent Infection or Cardiac Re-operation (1 Year)
Incidence of readmission for recurrent infection or cardiac re-operation (1 Year)
Measured: One year
Cost of Care
Cost of care
Measured: Through study completion, an average of one year

Timeline

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

16 Mar 202231 Oct 2024

First posted14 Dec 2021
Study start16 Mar 2022
Primary completion31 Oct 2024
Study completion31 Oct 2024

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for EndocarditisStudies of the same condition, open and under way.
More trials run by West Virginia UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05156437
Sponsor's protocol ID: 2109416021
Acronym: OPTIMAL
Status last verified: Apr 2026
First submitted: 16 Nov 2021
Last updated: 5 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 30152252
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.
PubMed 32227127
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.
PubMed 32665381
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.
PubMed 32240296
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.
PubMed 30605448
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.
PubMed 27800528
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.
PubMed 26557487
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.
PubMed 27325495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental

All Endocarditis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Postoperative Antibiotic Management Duration Following Surgery for Intravenous Drug Abuse (IVDA) Endocarditis (OPTIMAL)
ClinicalTrials.gov ID: NCT05156437
Acronym / sponsor ID: OPTIMAL / 2109416021
Conditions: Endocarditis
Keywords: Intravenous Drug Abuse Endocarditis, Oral Antibiotics, IV Antibiotics
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 5 participants (actual)
Lead sponsor: West Virginia UniversityUniversity, hospital or other
Study start: 16 Mar 2022 (actual)
Primary completion: 31 Oct 2024 (actual)
Study completion: 31 Oct 2024 (actual)
First posted: 14 Dec 2021 (actual)
Results: Posted 5 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Group I (Experimental)	Experimental	Drug: Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin, Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, CeftarolineTwo (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	Drug: Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, CeftarolineConventional 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, RifampicinAmoxycillin, Cefalexin, Dicloxacillin, Linezolid, Levofloxacin, Rifampicin	Drug	Group I (Experimental)
Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, CeftarolineAmpicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime, Ceftaroline	Drug	Group I (Experimental), Group II (Control Group)

Primary outcome

All-cause Mortality at Six (6) Months Post-surgery.
Time frame: Six months
Incidences of all-cause mortality at six (6) months post-surgery.
All-cause Mortality at (12) Months Post-surgery.
Time frame: One year
Incidences of all-cause mortality at (12) months post-surgery.
Incidence of Recurrent Blood Culture Positive Infection (6 Month)
Time frame: Six months
Incidence of recurrent blood culture positive infection (6 month)
Incidence of Recurrent Blood Culture Positive Infection (1 Year)
Time frame: One year
Incidence of recurrent blood culture positive infection (1 year)
Incidence of Cardiac Re-operation (6 Month)
Time frame: Six months
Incidence of cardiac re-operation (6 Month)
Incidence of Cardiac Re-operation (1 Year)
Time frame: One year
Incidence of cardiac re-operation (1 Year)

3 secondary outcomes

Readmission for Recurrent Infection or Cardiac Re-operation (6 Month)
Time frame: Six months
Readmission for Recurrent Infection or Cardiac Re-operation (1 Year)
Time frame: One year
Cost of Care
Time frame: Through study completion, an average of one year

Results and safety

Results posted to the registry on 5 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group I (Experimental)	4	0
Group II (Control Group)	1	0

Primary outcome: All-cause Mortality at Six (6) Months Post-surgery.

Time frame: Six months

Population analysed: 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.

Primary outcome: All-cause Mortality at (12) Months Post-surgery.

Time frame: One year

Population analysed: 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.

Primary outcome: Incidence of Recurrent Blood Culture Positive Infection (6 Month)

Time frame: Six months

Primary outcome: Incidence of Recurrent Blood Culture Positive Infection (1 Year)

Time frame: One year

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse events were collected, monitored or assessed at any time during the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group I (Experimental)	0 of 0	0 of 0	0
Group II (Control Group)	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30152252Iversen 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.
Background: PubMed 32227127Spellberg 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.
Background: PubMed 32665381Lemaignen 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.
Background: PubMed 32240296Brown 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.
Background: PubMed 30605448Scholl 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.
Background: PubMed 27800528Wurcel 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.
Background: PubMed 26557487Kornbau 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.
Background: PubMed 27325495Badhwar 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.

Related trials for Endocarditis

Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vinay Badhwar, MD principal investigator

West Virginia University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 May 2026. 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 United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality at Six (6) Months Post-surgery. (time frame: Six months). The study lists 6 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 NCT05156437, which also lists 8 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 5 May 2026.