Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Strep… (NCT06126263) | Clinical Trial Compass
UnknownNot Applicable
Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections
United States1,000 participantsStarted 2023-01-01
Plain-language 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
Who can participate
Age range18 Years – 100 Years
SexALL
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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)
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)
What they're measuring
1
In hospital mortality or discharge to hospice
Timeframe: Hospital stay
Trial details
NCT IDNCT06126263
SponsorNational Institutes of Health Clinical Center (CC)