Bacterial ResistanceSATURNNCT01208519
SATURN 04 Nosocomial Acquisition Study
An observational study of Bacterial Resistance and Infection Resistant to Multiple Drugs, run by Catholic University of the Sacred Heart at 3 sites in 3 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Resistance, Infection Resistant to Multiple Drugs, Staph Aureus Methicillin Resistant Colonization
- How many people
- 16,680 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2010to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All hospitalized non ICU patients at hospital admission/discharge;
- Age >18 years old;
- All patients starting intravenous and/or oral antibiotic treatments during hospitalization.
Who cannot join
- Pregnancy;
- Recent nose surgery (for nasal swabs).
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Italy1 site
Università Cattolica del Sacro Cuore; Policlinico A. Gemelli
Rome, Lazio, 00100
About this study
Official title: Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria in Hospitalised Patients (SATURN 04)
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.
Read the 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
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years (January 2015)
Secondary outcomes (1)
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.
Measured: 5 years (January 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bacterial ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Centre of Serbia, National Institute of Infectious Diseases Matei Bals, University Hospital, Geneva, Canisius-Wilhelmina Hospital, Universiteit Antwerpen
- Investigators
- Evelina Tacconelli, MD PhD, Study chair, Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208519
- Sponsor's protocol ID
- FP7-N° 241796
- Acronym
- SATURN
- Status last verified
- Nov 2012
- First submitted
- 23 Sep 2010
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32379042Tacconelli 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.
PubMed 31128285Meletiadis 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.
PubMed 28807914De 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.
PubMed 22458427
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Specific Antibiotic Therapies on the Prevalence of Human Host Resistant Bacteria in Hospitalised Patients (SATURN 04)
- ClinicalTrials.gov ID
- NCT01208519
- Acronym / sponsor ID
- SATURN / FP7-N° 241796
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16,680 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Clinical Centre of Serbia, National Institute of Infectious Diseases Matei Bals, University Hospital, Geneva, Canisius-Wilhelmina Hospital, Universiteit Antwerpen
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2015
- First posted
- 24 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- All hospitalized non ICU patients at hospital admission/discharge;
- Age >18 years old;
- All patients starting intravenous and/or oral antibiotic treatments during hospitalization.
Key exclusion criteria (2 listed)
- Pregnancy;
- Recent nose surgery (for nasal swabs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of different antibiotics in selecting antimicrobial resistance in in-patients
Time frame: 5 years (January 2015)
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.
1 secondary outcome
Colonization and infection risk according to antibiotic treatment duration
Time frame: 5 years (January 2015)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
- Derived from this study: PubMed 32379042Niehus 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.
- Derived from this study: PubMed 31128285Tacconelli 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.
- Derived from this study: PubMed 28807914Meletiadis 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.
- Derived from this study: PubMed 22458427De 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.
- European Commission websiteLink provided by the sponsor.
- Website of Policlinico A. Gemelli, RomaLink provided by the sponsor.
- Università Cattolica Sacro Cuore, RomaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelina Tacconelli, MD PhD study chair
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli - Roma
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Resistance and Infection Resistant to Multiple Drugs, run by Catholic University of the Sacred Heart at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, Romania, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of different antibiotics in selecting antimicrobial resistance in in-patients (time frame: 5 years (January 2015)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01208519, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2013.