Streptococcal SepsisiGASAntitoxNCT06126263
Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections
An observational study of Streptococcal Sepsis and Invasive Group A Beta-Haemolytic Streptococcal Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Streptococcal Sepsis, Invasive Group A Beta-Haemolytic Streptococcal Disease, Necrotizing Soft Tissue Infection
- What is being tested?
- Linezolid and Clindamycin
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult inpatients with culture confirmed proven or probable invasive monomicrobial GAS in the PINC AI (TM) Database admitted between 2015-2021 who receive a β-lactam therapy for a minimum of 3 days within 3 days of culture will be eligible for inclusion in the emulated trial. Patient will be included if they then receive an anti-toxin therapy within 3 days of culture being drawn, as long as B-lactam therapy has been initiated prior or on the same day as antitoxin therapy.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center (primary center conducting large database study)
Bethesda, Maryland, 20892
About this study
Official title: Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation
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
- Conditions
- Streptococcal Sepsis, Invasive Group A Beta-Haemolytic Streptococcal Disease, Necrotizing Soft Tissue Infection, Infection, Bloodstream, Infection, Bacterial, Streptococcal Toxic Shock Syndrome
- Being tested
- Linezolid, Clindamycin
- Keywords
- Invasive GAS, necrotizing soft tissue infection, streptococcal toxic shock syndrome, linezolid, clindamycin, anti-toxin therapy
- Medical subject headings
- Sepsis, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LinezolidDrug
Adjunctive antitoxin therapy
ClindamycinDrug
Adjunctive antitoxin therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality or discharge to hospice
In hospital mortality or discharge to hospice
Measured: Hospital stay
Secondary outcomes (2)
Length of stay among survivors
Duration of hospitalization among surviving participants
Measured: Hospital stay
Clostridioides difficile infection
- 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)
Measured: Within hospital stay of interest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcal SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Emory University
- Responsible party
- Principal investigator, Sameer Kadri, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Ahmed Babiker, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126263
- Sponsor's protocol ID
- BD022389
- Acronym
- iGASAntitox
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Adjunctive Clindamycin Versus Linezolid for β-lactam Treated Patients With Invasive Group A Streptococcal Infections: A Target Trial Emulation
- ClinicalTrials.gov ID
- NCT06126263
- Acronym / sponsor ID
- iGASAntitox / BD022389
- Conditions
- Streptococcal Sepsis, Invasive Group A Beta-Haemolytic Streptococcal Disease, Necrotizing Soft Tissue Infection, Infection, Bloodstream, Infection, Bacterial, Streptococcal Toxic Shock Syndrome
- Keywords
- Invasive GAS, necrotizing soft tissue infection, streptococcal toxic shock syndrome, linezolid, clindamycin, anti-toxin therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Collaborators
- Emory University
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult inpatients with culture confirmed proven or probable invasive monomicrobial GAS in the PINC AI (TM) Database admitted between 2015-2021 who receive a β-lactam therapy for a minimum of 3 days within 3 days of culture will be eligible for inclusion in the emulated trial. Patient will be included if they then receive an anti-toxin therapy within 3 days of culture being drawn, as long as B-lactam therapy has been initiated prior or on the same day as antitoxin therapy.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LinezolidAdjunctive antitoxin therapy | Drug | – |
| ClindamycinAdjunctive antitoxin therapy | Drug | – |
Primary outcome
In hospital mortality or discharge to hospice
Time frame: Hospital stay
In hospital mortality or discharge to hospice
2 secondary outcomes
Length of stay among survivors
Time frame: Hospital stay
Clostridioides difficile infection
Time frame: Within hospital stay of interest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Babiker principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcal Sepsis and Invasive Group A Beta-Haemolytic Streptococcal Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In hospital mortality or discharge to hospice (time frame: Hospital stay). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.