SATURN 04 Nosocomial Acquisition Study

NCT01208519 | Unknown DMC

• 1 other identifier: FP7-N° 241796
• Study Type: observational
• Target: 16,680
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Drug resistance, Microbial; Methicillin-Resistant Staphylococcus aureus; ESBL; Colonisation; Screening; Gram-negative

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Colonization and infection risk according to antibiotic treatment duration

  5 years (January 2015)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Pregnancy;
• Recent nose surgery (for nasal swabs).

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Clinical Centre of Serbia: collaborator
• National Institute of Infectious Diseases Matei Bals: collaborator
• University Hospital, Geneva: collaborator
• Canisius-Wilhelmina Hospital: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (3)

Università Cattolica del Sacro Cuore; Policlinico A. Gemelli

Rome, Lazio, 00100, Italy

Location

Institute of Infectious Diseases Matei Bals

Bucharest, 021105, Romania

Location

Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (4)

• Niehus R, van Kleef E, Mo Y, Turlej-Rogacka A, Lammens C, Carmeli Y, Goossens H, Tacconelli E, Carevic B, Preotescu L, Malhotra-Kumar S, Cooper BS. Quantifying antibiotic impact on within-patient dynamics of extended-spectrum beta-lactamase resistance. Elife. 2020 May 7;9:e49206. doi: 10.7554/eLife.49206.

  PMID: 32379042 DERIVED

• Tacconelli E, Gorska A, De Angelis G, Lammens C, Restuccia G, Schrenzel J, Huson DH, Carevic B, Preotescu L, Carmeli Y, Kazma M, Spanu T, Carrara E, Malhotra-Kumar S, Gladstone BP. Estimating the association between antibiotic exposure and colonization with extended-spectrum beta-lactamase-producing Gram-negative bacteria using machine learning methods: a multicentre, prospective cohort study. Clin Microbiol Infect. 2020 Jan;26(1):87-94. doi: 10.1016/j.cmi.2019.05.013. Epub 2019 May 23.

  PMID: 31128285 DERIVED

• Meletiadis J, Turlej-Rogacka A, Lerner A, Adler A, Tacconelli E, Mouton JW; the SATURN Diagnostic Study Group. Amplification of Antimicrobial Resistance in Gut Flora of Patients Treated with Ceftriaxone. Antimicrob Agents Chemother. 2017 Oct 24;61(11):e00473-17. doi: 10.1128/AAC.00473-17. Print 2017 Nov.

  PMID: 28807914 DERIVED

• De Angelis G, Restuccia G, Venturiello S, Cauda R, Malhotra-Kumar S, Goossens H, Schrenzel J, Tacconelli E. Nosocomial acquisition of methicillin-resistant Staphyloccocus aureus (MRSA) and extended-spectrum beta-lactamase (ESBL) Enterobacteriaceae in hospitalised patients: a prospective multicenter study. BMC Infect Dis. 2012 Mar 29;12:74. doi: 10.1186/1471-2334-12-74.

  PMID: 22458427 DERIVED

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal and rectal swabs

Study Officials

• Evelina Tacconelli, MD PhD

  Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: September 24, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2015
• Last Updated: February 13, 2013

Record last verified: 2012-11

Locations

IT (1); RO (1); SE (1)