Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05977868
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-12
First Post:
2023-07-14
Brief Title:
Comparing Oral Versus Parenteral Antimicrobial Therapy
Sponsor:
West Virginia University
Organization:
West Virginia University
Study Overview
Official Title:
Comparing Oral Versus Parenteral Antimicrobial Therapy COPAT Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPAT
Brief Summary:
This is an investigator initiated multisite pragmatic randomized controlled trial designed to demonstrate equivalent effectiveness with improved safety of early transition from intravenous IV antimicrobial therapy to complex outpatient oral antimicrobial therapy COpAT across various infectious diseases endovascular bone and joint skin and soft tissue pulmonary gastrointestinal and genitourinary infections
All patients referred for outpatient parenteral antimicrobial therapy OPAT will be evaluated by the research team with respect to inclusionexclusion criteria If determined eligible for enrollment patients will be approached by a study investigator who will present the COPAT Trial Once informed consent is obtained patients will be randomized 21 using computer software into experimental or control standard of care group respectively Experimental COpAT only on hospital discharge Control Conventional OPAT OPAT transitioned to COpAT later in outpatient setting or long-acting parenteral lipoglycopeptides Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2 6 and 12 weeks after hospital discharge At the 6-week ID Clinic follow-up patients will be asked to complete a patient satisfaction survey The following 2 primary outcomes will be assessed cure at 3 months using clinical resolution of infection and laboratory parameters improvement in inflammatory markers and adverse events related to antimicrobial therapyvascular access complication The following 3 secondary outcomes will be assessed overall readmission at 3 months readmission related to initial infection or antimicrobial therapyvascular access complication at 3 months and patient satisfaction at 6 weeks The experimental group is being compared to standard of care in current clinical practice
As this is a pragmatic clinical trial patients will not undergo additional invasive testing or procedures
All patients referred for outpatient parenteral antimicrobial therapy OPAT will be evaluated by the research team with respect to inclusionexclusion criteria If determined eligible for enrollment patients will be approached by a study investigator who will present the COPAT Trial Once informed consent is obtained patients will be randomized 21 using computer software into experimental or control standard of care group respectively Experimental COpAT only on hospital discharge Control Conventional OPAT OPAT transitioned to COpAT later in outpatient setting or long-acting parenteral lipoglycopeptides Both groups will be followed by an ID physician on the research team with in-person or telemedicine ID Clinic standard of care visits at 2 6 and 12 weeks after hospital discharge At the 6-week ID Clinic follow-up patients will be asked to complete a patient satisfaction survey The following 2 primary outcomes will be assessed cure at 3 months using clinical resolution of infection and laboratory parameters improvement in inflammatory markers and adverse events related to antimicrobial therapyvascular access complication The following 3 secondary outcomes will be assessed overall readmission at 3 months readmission related to initial infection or antimicrobial therapyvascular access complication at 3 months and patient satisfaction at 6 weeks The experimental group is being compared to standard of care in current clinical practice
As this is a pragmatic clinical trial patients will not undergo additional invasive testing or procedures
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None