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

NCT06126263 | Unknown

• 1 other identifier: BD022389
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• In hospital mortality or discharge to hospice

  In hospital mortality or discharge to hospice

  Hospital stay

Secondary Outcomes (2)

• Length of stay among survivors

  Hospital stay

• Clostridioides difficile infection

  Within hospital stay of interest

Interventions

Linezolid DRUG

Adjunctive antitoxin therapy

Clindamycin DRUG

Adjunctive antitoxin therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• Emory University: collaborator

Study Sites (1)

National Institutes of Health Clinical Center (primary center conducting large database study)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Sepsis; Bacterial Infections

Interventions

Linezolid; Clindamycin

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Study Officials

• Ahmed Babiker

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure Track Investigator

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2023
• Primary Completion: April 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)