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

- 11/17/20 - 1 form, 2 itemgroups, 8 items, 1 language
Itemgroups: 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

- 9/20/21 - 1 form, 7 itemgroups, 25 items, 1 language
Itemgroups: 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

- 9/17/21 - 8 forms, 29 itemgroups, 210 items, 1 language
Itemgroups: 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 itemgroups 168 items

Baseline-Visit 2

21 itemgroups 196 items

Test of Cure-Visit 17

23 itemgroups 160 items

EOT-Visit 16

23 itemgroups 165 items

Screening Visit

21 itemgroups 212 items

Unscheduled Visit

20 itemgroups 145 items

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

- 6/21/17 - 1 form, 1 itemgroup, 4 items, 1 language
Itemgroup: 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

- 10/13/16 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: 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

- 10/6/16 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: 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

- 10/6/16 - 1 form, 1 itemgroup, 8 items, 1 language
Itemgroup: 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

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

- 5/9/16 - 1 form, 9 itemgroups, 21 items, 1 language
Itemgroups: 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

- 2/15/16 - 1 form, 1 itemgroup, 1 item, 1 language
Itemgroup: 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.

SacBo PZ: Case Report Form AE Termination Signature DRKS00000084 NCT01143272 - SacBo PZ: Case Report Form AE Termination Signature Comment (optional)

- 2/15/16 - 1 form, 1 itemgroup, 2 items, 1 language
Itemgroup: Comment Log
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.

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

- 2/15/16 - 1 form, 1 itemgroup, 12 items, 1 language
Itemgroup: Adverse event
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.

SacBo TI: Case Report Form Phone Interview Diary TI DRKS00000084 NCT01143272 - SacBo TI: Case Report Form Phone Interview Diary TI NCT01143272

- 2/11/16 - 1 form, 3 itemgroups, 14 items, 1 language
Itemgroups: Current contact, Stool frequency and consistency, Intake of investigational agent
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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