Clinical Trials Logo

Clinical Trial Summary

The aim of the project is to perform a multinational, prospective, observational study on IAIs (IntraAbdominal Infections) in critically ill patients; special emphasis will be given to epidemiology and outcomes.


Clinical Trial Description

To investigate microbiology and/or drug resistance patterns related to: Geographical region, Source of IAI, Upper GI tract perforation (stomach & duodenum), Lower GI tract perforation (jejunum, ileum, colon, rectum), Primary peritonitis, Peritoneal dialysis-related peritonitis, Intra-abdominal abscess, Pancreatic infection, Biliary tract infection, Typhlitis, Toxic megacolon.

To check the Origin of IAI: community-acquired, early-onset healthcare-associated, late-onset healthcare-associated.

To describe physician's antimicrobial prescription patterns related to a classification grid that stratifies IAIs according to disease expression, community or healthcare origin, and anatomical disruption.

To investigate outcomes (clinical response, need for surgical revision, length of hospitalization, and mortality) related to: Classification of IAI, Severity of acute illness at time of diagnosis (SOFA score) and clinical response after 48-72 hrs. (SOFA score), Processes of care (Time to 1st antimicrobial dose, Time to source control, Type of source control intervention (laparotomy, percutaneous drainage, high volume peritoneal lavage, restoration of anatomy and function), Need for (unplanned) surgical revision (uncontrolled infection source), Frequency of microbiological sampling and delay of results)), Pathogens involved and empirical antimicrobial coverage; special emphasis will be given, to coverage of multidrug resistant Enterobacteriaceae, Pseudomonas aeruginosa, enterococci and Candida species, Duration of antimicrobial therapy, Underlying conditions ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02442596
Study type Observational
Source European Society of Intensive Care Medicine
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date April 2, 2017

See also
  Status Clinical Trial Phase
Withdrawn NCT04240288 - Procalcitonin Guided Antibiotic Therapy N/A
Completed NCT01431326 - Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Completed NCT01473836 - A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection Phase 3
Terminated NCT03354754 - LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Intra-abdominal Infection (cIAI) Phase 2
Completed NCT00965848 - A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections Phase 4
Completed NCT01506271 - Study of the Safety, Tolerability, and Efficacy of Relebactam (MK-7655) + Imipenem/Cilastatin Versus Imipenem/Cilastatin Alone to Treat Complicated Intra-Abdominal Infection [cIAI] (MK-7655-004) Phase 2
Completed NCT05628493 - Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction
Recruiting NCT04094818 - HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
Withdrawn NCT05639504 - Sepsis Prognosis and Diagnosis in the Emergency Department (SPEED)
Completed NCT00827541 - Post-Authorization Study Evaluating Safety Of Tigecycline N/A
Completed NCT01789905 - Tygacil Drug Use Investigation