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This study aims to compare 28-day mortality among patients with carbapenem resistant A. baumannii infections in two hypothetical target trials where patients receive 7 days of a cefiderocol-based treatment strategy or 7 days of a best available therapy treatment strategy.
please see uploaded study protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reciept of cefiderocol | Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy including cefiderocol. | ||
| Reciept of best available therapy (BAT) | Inpatients with carbapenem-resistant Acinetobacter baumannii infection that receive empiric and/or targeted therapy with activity against the infection but does not include cefiderocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Mortality | In hospital mortality or discharge to hospice during the hospital stay | During inpatient admission |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Duration of hospitalization among surviving patients | Inpatient admission |
| Recurrent CRAB Infection | clinical culture positive for carbapenem-resistant A. baumannii (CRAB) infection within the same encounter downstream of the index episode and within 30 days. |
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Inclusion Criteria:
Exclusion Criteria:
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Hospitalized adult patients with a clinical culture positive for carbapenem resistant A. baumannii and received an antibiotic with possible in vitro activity against carbapenem resistant A. baumannii in the time frame of interest (i.e., days before culture collection until 2 days after first available antibiotic susceptibility test result was made available) and admitted to US hospitals reporting to the PINC-AI healthcare database between 2018-2024 will be eligible for inclusion in the hypothetical target trials.
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| Name | Affiliation | Role |
|---|---|---|
| Sameer Kadri, MD | National Institutes of Health CC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
Aggregate data, analytic methods, and data dictionary will be shared upon request to the primary contact.
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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 | Sep 2, 2025 |
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| Within 30 days post discharge |
| Development of antibiotic resistance to initial antibiotic treatment | Development of antibiotic resistance on a subsequent positive clinical culture to an antibiotic administered during prior infectious episode | Subsequent admissions |
| Nov 6, 2025 |
| Prot_SAP_000.pdf |