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 range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

In hospital mortality or discharge to hospice

Timeframe: Hospital stay

Trial details

NCT IDNCT06126263

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Streptococcal Sepsis trials

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.