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

Infection, Bacterial Clinical Trial

— iGASAntitox  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06126263
• Other study ID #: BD022389
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: November 2023
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: June 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection, Bacterial
• Infections
• Invasive Group A Beta-Haemolytic Streptococcal Disease
• Necrotizing Soft Tissue Infection
• Sepsis
• Shock
• Shock, Septic
• Soft Tissue Infections
• Streptococcal Infections
• Streptococcal Sepsis

Intervention

Drug:
• Linezolid
Adjunctive antitoxin therapy
• Clindamycin
Adjunctive antitoxin therapy

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center (primary center conducting large database study)	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In hospital mortality or discharge to hospice	In hospital mortality or discharge to hospice	Hospital stay
Secondary	Length of stay among survivors	Duration of hospitalization among surviving participants	Hospital stay
Secondary	Clostridioides difficile infection	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)	Within hospital stay of interest