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Beta-lactam Antibiotic
Oral Antibiotics for Endocarditis (OPTIMAL Trial)
Phase 4
Waitlist Available
Led By Vinay Badhwar, MD
Research Sponsored by Vinay Badhwar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The age of the patient is ≥ 18
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year
Awards & highlights
OPTIMAL Trial Summary
This trial is testing if it's safe to switch from IV to oral antibiotics for people with endocarditis, a serious infection.
Who is the study for?
Adults over 18 who've had heart valve surgery for IVDA endocarditis and completed 2 weeks of post-op IV antibiotics with no remaining infection. They must be able to use a medication tracking tool and have stable living conditions without severe infections, cancer, immune issues, or poor drug absorption.Check my eligibility
What is being tested?
The trial is testing if switching from initial IV antibiotics to oral ones after uncomplicated IVDA endocarditis surgery is safe and effective. It aims to reduce hospital stays while ensuring patients can manage their treatment at home using a compliance tracking tool.See study design
What are the potential side effects?
Possible side effects include allergic reactions, gastrointestinal issues like nausea or diarrhea, potential liver or kidney problems due to long-term antibiotic use, and increased risk of developing antibiotic-resistant bacteria.
OPTIMAL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I've completed 2 weeks of IV antibiotics after surgery with no signs of infection.
Select...
I had heart valve surgery due to infection from IV drug use, with specific bacteria found in my blood.
OPTIMAL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perinatal death
To assess all-cause mortality at six (6) months post-surgery.
To assess cardiac re-operation.
+1 moreSecondary outcome measures
Cost of care
Readmission for recurrent infection or cardiac re-operation
OPTIMAL Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (Experimental)Experimental Treatment2 Interventions
Two (2) weeks of postoperative inpatient IV antibiotic therapy followed by four (4) weeks of oral therapy with outpatient follow-up.
Group II: Group II (Control Group)Active Control1 Intervention
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).
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Who is running the clinical trial?
Vinay BadhwarLead Sponsor
Vinay Badhwar, MDPrincipal InvestigatorWest Virginia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an ongoing infection in an organ or joint that is not related to my heart.I am 18 years old or older.I am able to follow the study's tracking tool requirements.I can use a mobile app to track my medication as confirmed by my doctor and care team.I've completed 2 weeks of IV antibiotics after surgery with no signs of infection.I need another heart valve surgery due to infection from IV drug use.I had heart valve surgery due to infection from IV drug use, with specific bacteria found in my blood.I need IV antibiotics for an ongoing infection.You don't have a stable home.My cancer is not in remission and requires ongoing or future treatment.I have not had serious infections like fungal or specific bacterial infections recently.You don't have good mobile phone service where you live.I cannot attend follow-up medical or psychiatric appointments.I am mentally capable of understanding and participating in the trial.I cannot take pills due to a stomach or bowel problem.My immune system is weaker than normal.I am unable to understand and agree to the study's details.You have a history of not following medical instructions regularly.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (Experimental)
- Group 2: Group II (Control Group)
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in this research initiative?
"This clinical trial is no longer accepting participants. It was unveiled on March 16th 2022 and the last edits were made October 27th of that same year. If you are searching for other research projects, there are currently 374 trials involving endocarditis, as well as 197 studies in need of Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone or Cefepime volunteers."
Answered by AI
Are there any remaining spots available in this research project?
"Unfortunately, this medical trial is not currently admitting participants. The most recent update for the study was on October 27th 2022; however, there are 374 studies related to endocarditis and 197 research projects involving Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone or Cefepime/Ceftaroline recruiting patients at present."
Answered by AI
What types of infections are Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime and Ceftaroline typically employed to cure?
"Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime and Ceftaroline are commonly used to treat communicable diseases such as staphylococcal infections (S. aureus), lower respiratory tract infection (lrti) and pneumonia."
Answered by AI
What potential adverse reactions could arise from using Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime or Ceftaroline?
"The safety of Ampicillin, Oxacillin, Vancomycin, Daptomycin, Ceftriaxone, Cefepime and Ceftaroline all scored a 3 on our Power scale as they are approved treatments in Phase 4 trials."
Answered by AI
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