Search results - Portal of Medical Data Models (MDM-Portal)

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit (Undefined)

- 9/20/21 - 4 forms, 10 itemgroups, 72 items, 2 languages

Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch

Study documentation part: Outpatient Department Visit (Undefined and with microbiology part). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Microbiology- Staphylococcus aureus characteristics

5 itemgroups 29 items

Microbiology- Summary sheet

4 itemgroups 23 items

Microbiology- Sputum, Serum and EDTA blood

3 itemgroups 13 items

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

- 9/20/21 - 1 form, 10 itemgroups, 72 items, 2 languages

Itemgroups: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch

Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Eligibility Staphylococcal Infections NCT00211913

- 12/23/16 - 1 form, 2 itemgroups, 12 items, 1 language

Itemgroups: Inclusion Criteria, Exclusion Criteria

StaphVAX in Cardiovascular Surgery Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00211913

Surveillance of healthcare associated infection: Staphylococcus aureus bacteraemia DSS Metadata Online Registry (METeOR)

- 7/24/16 - 1 form, 14 itemgroups, 26 items, 1 language

Itemgroups: Person 1, Person (name), Person 2, Person (address), Address 1, Person 3, Address 2, Episode of admitted patient care, Establishment 1, Person 4, Laboratory, Patient episode of Staphylococcus aureus bacteraemia, Methicillin-resistant Staphylococcus aureus isolate, Establishment 2

Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Surveillance of healthcare associated infection: Staphylococcus aureus bacteraemia DSS The purpose of this data set specification (DSS) is to support a comprehensive surveillance program of healthcare associated infections (HAI). HAIs are those infections that are not present or incubating at the time of admission to a healthcare program or facility, develop within a healthcare organisation or are produced by micro-organisms acquired during admission. This DSS is intended to support Staphylococcus aureus bacteraemia (SAB) surveillance in Australian hospitals. It is designed for the purposes of HAI surveillance, not diagnosis. The value of surveillance as part of a hospital infection control program is supported by high-grade international and national evidence. This DSS supports development of local forms and systems for surveillance of HAIs and associated data collection. This DSS applies to patient episodes of SAB in Australian hospitals. Case Definition – Healthcare associated Staphylococcus aureus bacteraemia (SAB) A patient-episode of Staphylococcus aureus bacteraemia (SAB) is a positive blood culture for Staphylococcus aureus. For surveillance purposes, only the first isolate per patient is counted, unless at least 14 days has passed without a positive culture, after which an additional episode is recorded. A SAB will be considered to be a healthcare-associated event if: EITHER • CRITERION A. The patient’s first SAB positive blood culture was collected more than 48 hours after hospital admission or less than 48 hours after discharge. OR • CRITERION B. The patient’s first positive SAB blood culture was collected less than or equal to 48 hours after hospital admission and one or more of the following key clinical criteria was met for the patient-episode of SAB: 1. SAB is a complication of the presence of an indwelling medical device (e.g. intravascular line, haemodialysis vascular access, CSF shunt, urinary catheter) 2. SAB occurs within 30 days of a surgical procedure where the SAB is related to the surgical site 3. SAB was diagnosed within 48 hours of a related invasive instrumentation or incision 4. SAB is associated with neutropenia (Neutrophils: less than 1 x 109/L) contributed to by cytotoxic therapy In order for jurisdictions and private hospital ownership groups to accurately report and monitor Healthcare Associated Infections, the data elements listed should be collected at hospital level for each patient-episode of Staphylococcus aureus bacteraemia. HAI patient episode data elements for SAB, by short name Data elements to be collected for each patient episode Data elements used for calculation of SAB rates Person identifier Patient days Family name Patient episodes of healthcare associated SAB Given name(s) Indigenous status Date of birth Sex Address line (person) Suburb/town/locality name (person) Australian state/territory identifier Australian postcode (address) Admission date Separation date Ward/clinical area Specimen collection date Specimen collection time Laboratory number Specimen identifier Laboratory result identifier Healthcare associated SAB clinical criteria Staphylococcus aureus bacteraemia status SAB methicillin susceptibility Antibiotic susceptibility (MRSA isolate) Antibiotic susceptibility indicator (MRSA isolate) Establishment number © Australian Institute of Health and Welfare 2015 Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 – (Patient Log)

- 11/2/15 - 1 form, 1 itemgroup, 10 items, 2 languages

Itemgroup: Patient Log

Study documentation part: (Patient Log). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 – (Centre-Log)

- 11/2/15 - 1 form, 1 itemgroup, 9 items, 2 languages

Itemgroup: Centre-Log

Study documentation part: (Centre-Log). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 Basic Data - Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760 <e2><80><93> Basic Data

- 11/1/15 - 1 form, 4 itemgroups, 12 items, 2 languages

Itemgroups: Basic data, Inclusion Criteria, Exclusion Criteria, Demography

Study documentation part: Basic Data. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

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