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| Name | Class |
|---|---|
| Emory University | OTHER |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linezolid | Drug | Adjunctive antitoxin therapy | ||
| Clindamycin | Drug | Adjunctive antitoxin therapy |
| Measure | Description | Time Frame |
|---|---|---|
| In hospital mortality or discharge to hospice | In hospital mortality or discharge to hospice | Hospital stay |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay among survivors | Duration of hospitalization among surviving participants | Hospital stay |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Babiker | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center (primary center conducting large database study) | Bethesda | Maryland | 20892 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2023 |
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| Within hospital stay of interest |
| Nov 8, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D000069349 | Linezolid |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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