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Sepsis Case Report Form MEDUSA project - SAPS II- Score Report Form

- 17-11-20 - 1 Formulier, 2 Itemgroepen, 8 Data-elementen, 1 Taal

Itemgroepen: Header module, SAPS II- Score

The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

Input Data Elements CDSS Antibiotic Stewardship Leibovici 2007

- 20-09-21 - 1 Formulier, 7 Itemgroepen, 25 Data-elementen, 1 Taal

Itemgroepen: Demographics, Acquisition of infection, Relevant background conditions, Sepsis presentation, Antibiotic exposure, Evidence for the site of infection, Microbiology

Input Data Elements from CDSS for Antibiotic Stewardship to show that decision support and prediction using causal probabilistic networks improves the patients' outcomes, because it leads to high procentage of appropriate empirical antibiotic treatment resulting in reduction of complications, mortality and hospital stay, published by Leibovici et al. 2007

REJUVENATE NCT02655419 - Treatment 1-3 Visit 3-5

- 17-09-21 - 8 Formulieren, 29 Itemgroepen, 210 Data-elementen, 1 Taal

Itemgroepen: Administrative Information, Infection-related Examination, Infection related Signs and Symptoms, Post-Operative Wound Examination, Wound Infection, Signs and Symptoms of Wound Infection, Vital Signs examination, Temperature, Study drug loading dose, Study drug administration ATM-AVI, Study drug administration Metronidazole, Surgical Procedure, Description of Findings, Microbiology, Overdose Report, Overdose Report, Lab Values, Laboratory procedures, Liver Diagnostic Assessments, Liver Diagnostic, Liver risk factors, Liver risk factors, Liver signs and symptoms, Liver signs and symptoms, Administrative Information, Electrocardiogram (ECG), Administrative Information, PK sample Central Lab, Pharmakokinetics Sampling at Day 4

A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults. NCT02655419 Sponsors and Collaborators: Pfizer Innovative Medicines Initiative (IMI) COMBACTE-CARE Investigators: Study Director:Pfizer CT.gov Call Center;Pfizer Principal Investigator:Oliver Cornely;Clinical Trials Centre Cologne

Late Followup-Visit 18

23 Itemgroepen 168 Data-elementen

Baseline-Visit 2

21 Itemgroepen 196 Data-elementen

Test of Cure-Visit 17

23 Itemgroepen 160 Data-elementen

EOT-Visit 16

23 Itemgroepen 165 Data-elementen

Screening Visit

21 Itemgroepen 212 Data-elementen

Unscheduled Visit

20 Itemgroepen 145 Data-elementen

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GSK Study ID 104864-201 Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication - Supportive Therapies-Transfusions, Anti-Infectives and Concominant Medication

- 24-04-18 - 1 Formulier, 6 Itemgroepen, 23 Data-elementen, 1 Taal

Itemgroepen: Identification Numbers, Supportive Therapy Transfusion, If Yes to Supportive Therapy (Including Erythropoietin), Supportive Anti-Infective Therapy, If Yes to Supportive Anti-Infective Therapy, Concominant Medication

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Eligibility Antibiotics in Critical Care Patients DRKS00004426 NCT01793012 DRKS00004426 - Eligibility Antibiotics in Critical Care Patients NCT01793012 DRKS00004426

- 26-06-17 - 1 Formulier, 2 Itemgroepen, 12 Data-elementen, 1 Taal

Itemgroepen: Inclusion Criteria, Exclusion Criteria

Responsible Party: Michael Zoller MD, senior physician, Ludwig-Maximilians - University of Munich ClinicalTrials.gov Identifier: NCT01793012 History of Changes Other Study ID Numbers: MUC 428-12 DRKS00004426 ( Other Identifier: German clinical trials register ) Study First Received: January 24, 2013 Last Updated: March 30, 2015 Drug Monitoring of Antibiotics in Critical Care Patients (DRAK) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01793012

Antibiotic-associated Diarrhoea SacBo TI DRKS00000084 NCT01143272 DRKS00000084 - Basic Information Registration

- 21-06-17 - 1 Formulier, 1 Itemgroep, 4 Data-elementen, 1 Taal

Itemgroep: Registration

https://clinicaltrials.gov/ct2/show/NCT01143272 Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Input Data Elements CDSS Antibiotic Stewardship Pogue 2014

- 13-10-16 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal

Itemgroep: Eligibility criteria

Input Data Elements CDSS for Antibiotic Stewardship to access the impact of automated alerts coupled with antibiotic stewardship intervention on patient outcomes. Published by Pogue et al. 2014

Input Data Elements CDSS Antibiotic Stewardship Madaras-Kelly 2006

- 06-10-16 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal

Itemgroep: Prescription

Input Data Elements CDSS to evaluate whether an intervention to limit fluoroquinolone use is associated with a lower rate of nosocomial MRSA infection, published by Madras-Kelly et al. 2006

Input Data Elements CDSS Antibiotic Stewardship Buising 2008

- 06-10-16 - 1 Formulier, 1 Itemgroep, 8 Data-elementen, 1 Taal

Itemgroep: Restricted antibiotics

Input Data Elements from CDSS for evaluation of impact of a novel computerized antimicrobial approval system on antibiotic-prescribing behaviour in a hospital, published by Buising et al. 2008

Palliative and Hospice Care Antibiotics In Palliative Medicine

- 10-05-16 - 1 Formulier, 4 Itemgroepen, 24 Data-elementen, 2 Talen

Itemgroepen: Indication for antibiotic treatment, Antibiotic application, Antibiotic use, No use of antibiotics

https://www.hope-clara.de/ The HOPE Hospice and Palliative Care Recording standard documentation is used for documentation of palliative care and as an instrument for quality assurance in pallatiave wards, hospices and oncological wards as well as in ambulatory services and palliative teams.

Case Report Form Day 5 MEDUSA project - Diagnosis of blood culture report form

- 09-05-16 - 1 Formulier, 9 Itemgroepen, 21 Data-elementen, 1 Taal

Itemgroepen: Header module, Day 5 - general aspects of treatment, Blood culture results, Blood culture result from primary source of infection, Therapy alterations within first five days of treatment, Clinical outcome, Day 28, Discharge from intensive care unit, hospital discharge

The MEDUSA project (medical education for sepsis source control and antibiotics) is a scientific study of the integrated research and treatment center "Center for Sepsis Control and Care" (CSCC) of the University Hospital Jena, Thuringia, Germany. Its aim is to investigate whether a multimodal and interdisciplinary training concept for the early recognition and standardized treatment of patients with sepsis improves time to administration of first antibiotic and survival of patients. Original forms obtained from: http://www.medusa.uniklinikum-jena.de/Datenerfassung.html

SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272 - SacBo PZ: Case Report Form AE Termination Signature Signature

- 15-02-16 - 1 Formulier, 1 Itemgroep, 1 Data-element, 1 Taal

Itemgroep: Investigator's electronic signature

Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

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