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

NCT ID: NCT06126263

Last Updated: 2023-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Linezolid

Adjunctive antitoxin therapy

Intervention Type DRUG

Clindamycin

Adjunctive antitoxin therapy

Intervention Type DRUG

Eligibility Criteria

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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)

* 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)

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Responsible Party

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Sameer Kadri, M.D.

Tenure Track Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Babiker

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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

Bethesda, Maryland, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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BD022389

Identifier Type: -

Identifier Source: org_study_id

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