iGASAntitox: Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections

Sponsor

National Institutes of Health Clinical Center (CC) (NIH)

Overall Status

Active, not recruiting

CT.gov ID

NCT06126263

Collaborator

Emory University (Other)

1,000

Enrollment

Location

17.9

Anticipated Duration (Months)

55.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Streptococcal Sepsis Invasive Group A Beta-Haemolytic Streptococcal Disease Necrotizing Soft Tissue Infection Infection, Bloodstream Infection, Bacterial Streptococcal Toxic Shock Syndrome	Drug: Linezolid Drug: Clindamycin

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Outcome Measures

Primary Outcome Measures

In hospital mortality or discharge to hospice [Hospital stay]
In hospital mortality or discharge to hospice

Secondary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)