SATURN 04 Nosocomial Acquisition Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Clinical Centre of Serbia
National Institute of Infectious Diseases Matei Bals
University Hospital, Geneva
Canisius-Wilhelmina Hospital
Universiteit Antwerpen
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT01208519
First received: September 23, 2010
Last updated: February 12, 2013
Last verified: November 2012
  Purpose

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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria in Hospitalised Patients (SATURN 04)

Resource links provided by NLM:


Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Impact of different antibiotics in selecting antimicrobial resistance in in-patients [ Time Frame: 5 years (January 2015) ] [ Designated as safety issue: No ]
    Rate of acquisition of target antibiotic-resistant bacteria by 1,000 antibiotic-days in hospitalized patients will be calculated. The rate will be also defined according to antibiotic class and single drug.


Secondary Outcome Measures:
  • Colonization and infection risk according to antibiotic treatment duration [ Time Frame: 5 years (January 2015) ] [ Designated as safety issue: No ]
    Rate of nosocomial infections by 1,000 days of hospitalization in patients undergoing antibiotic therapy will be calculated.


Biospecimen Retention:   Samples Without DNA

Nasal and rectal swabs


Estimated Enrollment: 16680
Study Start Date: November 2010
Estimated Study Completion Date: January 2015
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case Control Study 1
To define the impact of antibiotics on new acquisition of MRSA and ESBL-producing gram negative bacteria, a matched case-control study will be done (ratio 1:4). The control group will be selected among patients not receiving antibiotics, admitted in the same ward on the day of the corresponding case, with negative cultures at hospital admission. Matching criteria will include: age (±5 years), sex, and total length of hospitalization.
Case control study 2
To define individual level of risk related to specific antibiotics, patients acquiring MRSA and ESBL-producing gram negative bacteria will be compared with patients not acquiring antibiotic-resistant strains after starting antibiotic therapy (ratio 1:4). Previously known risk factors or clinically relevant significant variables from the univariate analysis will be considered for inclusion in multivariate logistic regression analysis.

Detailed Description:

Nasal samples for the detection of MRSA and rectal samples (stoma sample in case of colostomy) for ESBL producing gram negative bacteria will be obtained at hospital admission and discharge. Patients starting antibiotic therapy per os and/or intravenously will be sampled at antibiotic start (t0, within one hour) and at the following intervals: day 3 (t1), 7 (t2), 15 (t3), 30 (t4). Patients colonized with MRSA and/or ESBL-producing gram negative bacteria before starting antibiotic therapy (t0 sample) will be excluded from follow-up cultures and analysis. All patients included in the study will be followed to determine whether they develop clinical infections with the target ARB. Patients will be followed during the hospitalization and afterwards for a total of 30-day from the inclusion in the study. Screening will be performed in outpatient clinics after patients' discharge from the hospital within 30 days of starting antibiotic (t0 sample).

Nasal and rectal cultures will be also obtained from the ward staff at the beginning and at the end of the study. This group includes nurses and all staff including doctors having contacts with patients. These cultures will be handled in the same manner as the patients' cultures

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients will be screened at hospital admission and hospital discharge during the study period. Patients colonised with MRSA and/or ESBL-producing gram-negative bacteria before starting antibiotic therapy will be excluded from follow-up cultures and analysis.

Patients starting antibiotic therapy per os and/or intravenously will be sampled at antibiotic start (t0, within one hour) and at the following intervals: day 3 (t1), 7 (t2), 15 (t3), 30 (t4). Screening will be performed in outpatient clinics after patients' discharge from the hospital.

Criteria

Inclusion Criteria:

  • All hospitalized non ICU patients at hospital admission/discharge;
  • Age >18 years old;
  • All patients starting intravenous and/or oral antibiotic treatments during hospitalization.

Exclusion Criteria:

  • Pregnancy;
  • Recent nose surgery (for nasal swabs).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208519

Locations
Italy
Università Cattolica del Sacro Cuore; Policlinico A. Gemelli
Rome, Lazio, Italy, 00100
Romania
Institute of Infectious Diseases Matei Bals
Bucharest, Romania, 021105
Serbia
Clinical Center of Serbia
Beograd, Serbia, 11000
Sponsors and Collaborators
Catholic University of the Sacred Heart
Clinical Centre of Serbia
National Institute of Infectious Diseases Matei Bals
University Hospital, Geneva
Canisius-Wilhelmina Hospital
Universiteit Antwerpen
Investigators
Study Chair: Evelina Tacconelli, MD PhD Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
  More Information

Additional Information:
No publications provided by Catholic University of the Sacred Heart

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Evelina Tacconelli, Catholic University of the Sacred Heart; Policlinico A. Gemelli, Rome
ClinicalTrials.gov Identifier: NCT01208519     History of Changes
Other Study ID Numbers: FP7-N° 241796
Study First Received: September 23, 2010
Last Updated: February 12, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Catholic University of the Sacred Heart:
Drug resistance, Microbial
Methicillin-Resistant Staphylococcus aureus
ESBL
Colonisation
Screening
Gram-negative

Additional relevant MeSH terms:
Infection
Communicable Diseases

ClinicalTrials.gov processed this record on September 22, 2014