MedTrace Logo

SATURN 04 Nosocomial Acquisition Study

NCT01208519 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 16680

Last updated 2013-02-13

No results posted yet for this study

Summary

The study is the WP4 of the EU-funded (7th FW) project SATURN (Impact of Specific Antibiotic Therapies on the prevalence of hUman host ResistaNt bacteria). A total of 6 surgical and 6 medical wards will participate in the study. Sites of the study are located in 3 countries (Italy, Serbia, Romania). This WP will compare nosocomial acquisition rates of methicillin-resistant Staphylococcus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL)-producing gram-negative bacteria (E.coli, Klebsiella spp. and Proteus spp.) among different treatment groups and define the temporal relationship between the start of antibiotic therapy, the acquisition of new colonisation in patients previously not colonised, and the development of a bacterial infection caused by the same strain isolated in a screening sample. This goal will be achieved by completing the following primary objectives:

* To determine the rate of acquisition of target antibiotic-resistant bacteria by 1,000 antibiotic-days according to different classes of antibiotics, duration of therapy and antibiotic combination (monotherapy versus combination therapy);
* To determine genotypic relation between colonising and infecting strain in the same patient and patients' and hospital staff colonising strains (to be performed in collaboration with WP1 of the SATURN project);
* To study the virulence and fitness of the isolates (i.e. new colonising strains) causing subsequent nosocomial infections (to be performed in collaboration with WP1 of SATURN project);
* To predict the risk for nosocomial infections due to target bacteria after a single treatment therapy adjusted by length of hospitalisation and ward colonisation pressure.

Conditions

  • Bacterial Resistance
  • Infection Resistant to Multiple Drugs
  • Staph Aureus Methicillin Resistant Colonization
  • Infection Due to ESBL Bacteria

Sponsors & Collaborators

  • Clinical Centre of Serbia

    collaborator OTHER

  • National Institute of Infectious Diseases Matei Bals

    collaborator UNKNOWN

  • University Hospital, Geneva

    collaborator OTHER

  • Canisius-Wilhelmina Hospital

    collaborator OTHER

  • Universiteit Antwerpen

    collaborator OTHER

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Evelina Tacconelli, MD PhD · Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-11-30
Completion
2015-01-31

Countries

  • Italy
  • Romania
  • Serbia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01208519 on ClinicalTrials.gov