Infection, Bacterial, Infection, Bloodstream, Invasive Group A Beta-Haemolytic Streptococcal Disease, Necrotizing Soft Tissue Infection, Streptococcal Sepsis, Streptococcal Toxic Shock Syndrome
Conditions
Keywords
Invasive GAS, necrotizing soft tissue infection, streptococcal toxic shock syndrome, linezolid, clindamycin, anti-toxin therapy
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 Group A streptococcus (GAS) between the years 2015-2021
Interventions
DRUGLinezolid
Adjunctive antitoxin therapy
DRUGClindamycin
Adjunctive antitoxin therapy
Sponsors
Emory University
National Institutes of Health Clinical Center (CC)
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In hospital mortality or discharge to hospice | Hospital stay | In hospital mortality or discharge to hospice |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay among survivors | Hospital stay | Duration of hospitalization among surviving participants |
| Clostridioides difficile infection | Within hospital stay of interest | C. difficile positive (PCR or antigen) result within same encounter downstream of the antitoxin therapy within 30 days and/or presence of a non present on admission (POA) C. difficile diagnosis code in conjugation with receipt of C. difficile therapy (PO/rectal vancomycin or PO fidaxomicin or IV metronidazole) |
Countries
United States
Outcome results
None listed