NAsal MEthicillin-resistant StaphylococcusPreMDRinLTCFNCT07234734
Prevalence of Multi-Drug Resistant Bacteria in Long-term Care Facilities
An observational study of NAsal MEthicillin-resistant Staphylococcus, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Antimicrobial resistance (AMR) is recognized as one of the major threats to global health [1], causing up to 25.000 deaths in the European Union every year, longer hospitalizations and increased healthcare costs. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- NAsal MEthicillin-resistant Staphylococcus
- How many people
- 581 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2023to 1 Jun 2024
- 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 1 year to 16 years
- All sexes
- Child
Study population: The population enrolled in this study will include all the patients admitted to the Paediatric Unit of the involved Hospitals during the study period that respect inclusion and exclusion criteria
Inclusion Criteria: · All the hospitalized children, aged between 1 and 16 years.
- Informed consent signed by parents or legal tutors
Exclusion Criteria: · All the hospitalized children admitted to the Unit of Oncologic/Hematologic disease or children affected with an hematologic disease also if admitted to the General Paediatric Ward.
- All the hospitalized children admitted to the Paediatric Intensive Care Unit (PICU)
- All the hospitalized children aged < 1 years old
- Children with parents or legal tutor who eventually refuse to sign the study consent form.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Malattie Infettive
Pavia, Pavia, 27100
About this study
Antimicrobial resistance (AMR) is recognized as one of the major threats to global health [1], causing up to 25.000 deaths in the European Union every year, longer hospitalizations and increased healthcare costs. It is well known that antimicrobial use is the main driving force towards AMR and up to 50% of antimicrobial prescriptions are either inappropriate or unnecessary [2]. It is then important to understand how to optimize antimicrobial usage not only in adults but also in infants, as they show different resistance patterns and have peculiar characteristics that may lead to incorrect administration and alteration of the pharmacokinetic and pharmacodynamic properties of the drug [3]. Antimicrobials are the most prescribed drugs in children [4][5] and this excessive usage has been recorded not only in developed countries, but also in low-income and middle-income ones [6]. In Europe, Italy reported one of the highest prescriptions rates, four times higher than the UK and six times higher than the Netherlands [7][8]. 84% of Italian infants in the community have already received at least one course of antibiotics at 2 years of age [9]. A point-prevalence survey (PPS) showed that 38.9% of hospitalized Italian infants received at least one antibiotic prescription both for treatment and prophylaxis; in children, the most commonly used antibiotic classes were third generation cephalosporins and penicillins plus enzyme inhibitors, with a high prescription rates of carbapenems and quinolones as well, often off-label [10]. In order to limit misuse and overuse of antibiotics in children, the joint SHEA-IDSA-PIDS position paper states the importance of introducing antimicrobial stewardship programs (ASPs) in all healthcare institutions [11].
Antimicrobial stewardship has been defined as "the optimal selection, dosage, and duration of antimicrobial therapy that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance" [12]. So far, little progress has been made with developing pediatric ASPs, especially outside the United States healthcare system.
Read more
One of the most important studies conducted in Europe in this field, the ARPEC project, was designed as a PPS: this type of strategy is very useful if repeated regularly, as it allows to monitor prescription trends over time and to identify the problem of inappropriate antibiotic usage [13]. However, it has been shown that PPSs are not sufficient by themselves to change the clinical practice if not combined with other methods [14], such as pre-prescription authorization, prospective audit and feedback, educational and training programmes or technological means of support. In USA, methicillin-resistant Staphylococcus aureus (MRSA) in children mainly causes skin and soft tissue infections but invasive diseases were increasingly reported in 1995-2010 [15]. Studies on MRSA carriage in healthy children showed great geographic variation (from less than 1% in Belgium to 15% in Taiwan) that depend on many local differences [16]. Nevertheless, very few studies have been performed on the influence of antibiotic prescription in the acquisition of resistant microorganism such MRSA in pediatric population.
The aim of this study is to estimate the incidence of MRSA nasal colonization and invasive disease and to investigate the impact of antibiotic treatment during hospitalization on the acquisition of MRSA nasal colonization in children
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of 30-days cumulative incidence of new MRSA nasal colonization in hospitalized pediatric patient.
Measured: 30 days
Secondary outcomes (1)
Comparison of cumulative incidence of new MRSA nasal colonization between pediatric patients who received an antibiotic treatment and those who didn't receive it during hospitalization.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start5 Sep 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAsal MEthicillin-resistant StaphylococcusStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 581 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Asperges, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234734
- Sponsor's protocol ID
- PreMDRinLTCF
- Acronym
- PreMDRinLTCF
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Multi-Drug Resistant Bacteria in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT07234734
- Acronym / sponsor ID
- PreMDRinLTCF / PreMDRinLTCF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 581 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 18 Nov 2025 (actual)
- 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.
Antimicrobial resistance (AMR) is recognized as one of the major threats to global health [1], causing up to 25.000 deaths in the European Union every year, longer hospitalizations and increased healthcare costs. It is well known that antimicrobial use is the main driving force towards AMR and up to 50% of antimicrobial prescriptions are either inappropriate or unnecessary [2]. It is then important to understand how to optimize antimicrobial usage not only in adults but also in infants, as they show different resistance patterns and have peculiar characteristics that may lead to incorrect administration and alteration of the pharmacokinetic and pharmacodynamic properties of the drug [3]. Antimicrobials are the most prescribed drugs in children [4][5] and this excessive usage has been recorded not only in developed countries, but also in low-income and middle-income ones [6]. In Europe, Italy reported one of the highest prescriptions rates, four times higher than the UK and six times higher than the Netherlands [7][8]. 84% of Italian infants in the community have already received at least one course of antibiotics at 2 years of age [9]. A point-prevalence survey (PPS) showed that 38.9% of hospitalized Italian infants received at least one antibiotic prescription both for treatment and prophylaxis; in children, the most commonly used antibiotic classes were third generation cephalosporins and penicillins plus enzyme inhibitors, with a high prescription rates of carbapenems and quinolones as well, often off-label [10]. In order to limit misuse and overuse of antibiotics in children, the joint SHEA-IDSA-PIDS position paper states the importance of introducing antimicrobial stewardship programs (ASPs) in all healthcare institutions [11].
Antimicrobial stewardship has been defined as "the optimal selection, dosage, and duration of antimicrobial therapy that results in the best clinical outcome for the treatment or prevention of infection, with minimal toxicity to the patient and minimal impact on subsequent resistance" [12]. So far, little progress has been made with developing pediatric ASPs, especially outside the United States healthcare system.
One of the most important studies conducted in Europe in this field, the ARPEC project, was designed as a PPS: this type of strategy is very useful if repeated regularly, as it allows to monitor prescription trends over time and to identify the problem of inappropriate antibiotic usage [13]. However, it has been shown that PPSs are not sufficient by themselves to change the clinical practice if not combined with other methods [14], such as pre-prescription authorization, prospective audit and feedback, educational and training programmes or technological means of support. In USA, methicillin-resistant Staphylococcus aureus (MRSA) in children mainly causes skin and soft tissue infections but invasive diseases were increasingly reported in 1995-2010 [15]. Studies on MRSA carriage in healthy children showed great geographic variation (from less than 1% in Belgium to 15% in Taiwan) that depend on many local differences [16]. Nevertheless, very few studies have been performed on the influence of antibiotic prescription in the acquisition of resistant microorganism such MRSA in pediatric population.
The aim of this study is to estimate the incidence of MRSA nasal colonization and invasive disease and to investigate the impact of antibiotic treatment during hospitalization on the acquisition of MRSA nasal colonization in children
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- The population enrolled in this study will include all the patients admitted to the Paediatric Unit of the involved Hospitals during the study period that respect inclusion and exclusion criteria
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
Estimation of 30-days cumulative incidence of new MRSA nasal colonization in hospitalized pediatric patient.
Time frame: 30 days
1 secondary outcome
Comparison of cumulative incidence of new MRSA nasal colonization between pediatric patients who received an antibiotic treatment and those who didn't receive it during hospitalization.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Related trials for NAsal MEthicillin-resistant Staphylococcus
RecruitingObservational study
NAsal MEthicillin-resistant Staphylococcus (NAMES): a Prospective Study to Assess the Impact of Antibiotic Therapy on Nasal Colonization with Methicillin-resistant Staphylococcus Aureus (MRSA) Inhospitalized Children
NAsal MEthicillin-resistant Staphylococcus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of NAsal MEthicillin-resistant Staphylococcus, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimation of 30-days cumulative incidence of new MRSA nasal colonization in hospitalized pediatric patient. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.