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Antibiotic
Oral vs IV Antibiotics for Infections (COPAT Trial)
Phase 4
Waitlist Available
Led By Joy J. Juskowich, MD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks after hospital discharge
Awards & highlights
COPAT Trial Summary
This trial will compare a new way to give antibiotics to patients to see if it's safer & just as effective as the usual way.
Who is the study for?
This trial is for English-speaking patients at select hospitals, transitioning to 2-8 weeks of IV antibiotics after discharge. They must be diagnosed with infections like endovascular, bone/joint, skin/soft tissue, lung, gut or urinary tract and able to follow up routinely. Excluded are those with drug use issues, unstable living situations or unable to consent.Check my eligibility
What is being tested?
The study compares early switch from IV antibiotics to oral therapy (COpAT) against standard care in treating various infections. Participants will be randomly assigned either COpAT upon hospital discharge or conventional treatment followed by COpAT later on. Outcomes measured include infection resolution and safety over a three-month period.See study design
What are the potential side effects?
Potential side effects may include reactions related to the broad range of antibiotics used such as stomach upset, allergic reactions, yeast infections due to antibiotic use and complications from long-term IV access if applicable.
COPAT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after hospital discharge
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after hospital discharge
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events related to antimicrobial therapy/vascular access complication
Cure at 3 months
Secondary outcome measures
Overall readmission at 3 months
Patient satisfaction
Readmission related to initial infection or antimicrobial therapy/vascular access complication at 3 months
COPAT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 (Experimental)Experimental Treatment1 Intervention
COpAT (oral antimicrobial therapy) on hospital discharge
Group II: Group 2 (Control)Active Control1 Intervention
Standard of care (IV antimicrobial therapy) on hospital discharge
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Who is running the clinical trial?
West Virginia UniversityLead Sponsor
176 Previous Clinical Trials
60,219 Total Patients Enrolled
1 Trials studying Pneumonia
74 Patients Enrolled for Pneumonia
Joy J. Juskowich, MDPrincipal InvestigatorWest Virginia University
Arif R. Sarwari, MD, MSc, MBAPrincipal InvestigatorWest Virginia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am unable to understand and give consent for treatment.I will start IV antibiotics for 2-8 weeks after leaving the hospital.I have been diagnosed with an infection in my blood vessels, bones, joints, skin, lungs, digestive system, or urinary system.I can participate in follow-up appointments, both in-person and via phone or video.My doctor thinks it's not safe for me to join this study.I cannot take pills or there's no effective pill-based treatment for my infection.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 (Experimental)
- Group 2: Group 2 (Control)
Awards:
This trial has 3 awards, including:- 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.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Group 1 (Experimental) satisfied the requirements of the FDA?
"Power estimates Group 1's safety to be a 3, as this is an authorized Phase 4 trial with ample evidence of its efficacy."
Answered by AI
Are there any vacancies available for participants in this experiment?
"Unfortunately, this medical study is not currently enrolling patients. Initially posted on August 1st 2023 and last edited July 24th 2023, the trial has yet to open admission again. However there are 755 other clinical trials actively recruiting at present."
Answered by AI
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