Clinical trial NCT06126263: Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections
Official title: Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Streptococcal Sepsis
Invasive Group A Beta-Haemolytic Streptococcal Disease
Necrotizing Soft Tissue Infection
Infection, Bloodstream
Infection, Bacterial
Streptococcal Toxic Shock Syndrome
Keywords: Invasive GAS
necrotizing soft tissue infection
streptococcal toxic shock syndrome
linezolid
clindamycin
anti-toxin therapy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: Emory University
First posted: 2023-11-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult inpatients with culture confirmed proven or probable invasive monomicrobial GAS in the PINC AI (TM) Database admitted between 2015-2021 who receive a β-lactam therapy for a minimum of 3 days within 3 days of culture will be eligible for inclusion in the emulated trial. Patient will be included if they then receive an anti-toxin therapy within 3 days of culture being drawn, as long as B-lactam therapy has been initiated prior or on the same day as antitoxin 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


Eligibility criteria: 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)

Primary outcomes:
measure: In hospital mortality or discharge to hospice
timeFrame: Hospital stay
Secondary outcomes:
measure: Length of stay among survivors
timeFrame: Hospital stay
measure: Clostridioides difficile infection
timeFrame: Within hospital stay of interest
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center (primary center conducting large database study)
state: Maryland
Study officials:
affiliation: Emory University
name: Ahmed Babiker
role: PRINCIPAL_INVESTIGATOR
References: