SATURN 04 Nosocomial Acquisition Study

Bacterial Resistance Clinical Trial

— SATURN  

Official title:

Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria in Hospitalised Patients (SATURN 04)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01208519
• Other study ID #: FP7-N° 241796
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2010
• Last updated: February 12, 2013
• Start date: November 2010
• Est. completion date: January 2015

Study information

• Verified date: November 2012
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16680
• Est. completion date: January 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Italy	Università Cattolica del Sacro Cuore; Policlinico A. Gemelli	Rome	Lazio
Romania	Institute of Infectious Diseases Matei Bals	Bucharest
Serbia	Clinical Center of Serbia	Beograd

Sponsors (6)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart	Canisius-Wilhelmina Hospital, Clinical Centre of Serbia, National Institute of Infectious Diseases Matei Bals, Universiteit Antwerpen, University Hospital, Geneva

Countries where clinical trial is conducted

Italy,  Romania,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of different antibiotics in selecting antimicrobial resistance in in-patients	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.	5 years (January 2015)	No
Secondary	Colonization and infection risk according to antibiotic treatment duration	Rate of nosocomial infections by 1,000 days of hospitalization in patients undergoing antibiotic therapy will be calculated.	5 years (January 2015)	No

External Links

•   European Commission website
•   Università Cattolica Sacro Cuore, Roma
•   Website of Policlinico A. Gemelli, Roma
•   Website of SATURN