Status:
UNKNOWN
Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
Emory University
Conditions:
Streptococcal Sepsis
Invasive Group A Beta-Haemolytic Streptococcal Disease
Eligibility:
All Genders
18-100 years
Brief Summary
This study aims to emulate a hypothetical target pragmatic multi-center, non-blinded trial of adult inpatients in the PINC AITM dataset with B-lactam treated culture confirmed monomicrobial invasive G...
Eligibility Criteria
Inclusion
- Adult inpatients patients (=\> 18 y of age)
- Monomicrobial Group A streptococcus invasive infection
- Primary therapy with a B-lactam agent (initiated before or on same day as adjunctive anti-toxin therapy)
Exclusion
- Patients with a polymicrobial GAS culture (non-GAS organisms identified on eligibility GAS culture)
- Patients who received linezolid but have a documented linezolid resistant isolate
- Patients with GAS infections of non-sterile non-invasive sites (i.e sites which do not meet above mentioned inclusion criteria) which include but not limited to the lower urinary tract, upper respiratory tract
- Patient with concomitant MSSA/MRSA invasive infection (+/- seven days of index GAS eligibility culture)
- Patients who receive both anti-toxin agents (violation of protocol)
- Patient who do not complete at least 3 days of B-lactam (violation of protocol)
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT06126263
Start Date
January 1 2023
End Date
June 30 2024
Last Update
November 13 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center (primary center conducting large database study)
Bethesda, Maryland, United States, 20892