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

Active, not recruiting

• Conditions: Streptococcal Sepsis; Infection, Bacterial; Necrotizing Soft Tissue Infection; Infection, Bloodstream; Invasive Group A Beta-Haemolytic Streptococcal Disease; Streptococcal Toxic Shock Syndrome

• Registration Number: NCT06126263
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-13
• Last Update Posted: 2023-11-13
• Primary Completion: 2024-04-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In hospital mortality or discharge to hospice	Hospital stay	In hospital mortality or discharge to hospice

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

National Institutes of Health Clinical Center (primary center conducting large database study); 🇺🇸 Bethesda, Maryland, United States