Acute IntoxicationNCT06291649
Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
An observational study of Acute Intoxication, run by Meyer Children's Hospital IRCCS at 31 sites in Italy.
Trial summary
Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings. Read more about this study
- Who is it for?
- Ages 1 month to 16 years
- Conditions the study is for
- Acute Intoxication
- How many people
- 90 participants
- Where
- 31 sitesItaly
- Study dates
- 5 Apr 2023to 5 Aug 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 month to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: subject between 1 month and 16 years that has reportet to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication
Who may be able to join
- Subjects between the ages of 1 month and 16 years who report to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication (defined as contact with a substance that is toxic per se or in such quantities as to cause a harmful effect on the body or administered by a route not intended for that substance)
Who cannot join
- not acquired informed consent
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
Italy31 sites, 31 recruiting
- Recruiting
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Firenze, 50139
Anna Chiara Azzali, 055 69361, annachiara.azzali@uslcentro.toscana.it
- Recruiting
Ospedale Maggiore
Bologna
Chiara Ghizzi, chiara.ghizzi@ausl.bologna.it
- Recruiting
Ospedale Centrale Bolzano
Bolzano
Ylenia Girtler, ylenia.girtler@sabes.it
- Recruiting
Ospedale Del Mugello
Borgo San Lorenzo, Firenze, 50139
Rosalia Emidia Di Silvio, rosaliaemidia.disilvio@uslcentro.toscana.it
- Recruiting
Ospedale Brotzu
Cagliari
Gabriella Cherchi, gacherchi@gmail.com
- Recruiting
Ospedale San Giuseppe
Empoli, 50053
Antonino Francesco Capizzi, antoninofrancesco.capizzi@uslcentro.toscana.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence, 50139
Marco De Luca, 0555662051, marco.deluca@meyer.it
- Recruiting
Ospedale G B Morgagni
Forlì, Forlì-Cesena
Melodie Aricò, melodieolivialoredanarosa.arico@auslromagna.it
- Recruiting
Ospedale Misericordia
Grosseto, 58100
Francesca Bonsignori, francesca.bonsignori@uslsudest.toscana.it
- Recruiting
Mater Salutis
Legnago, Verona
Anna Maria Colombaria, annamaria.colombari@aulss9.veneto.it
- Recruiting
Policlinico Messina
Messina
Laura Colavita, lauracol85@gmail.com
- Recruiting
Ospedale San Francesco
Nuoro
Antonio Cualbu, antonio.cualbu@atssardegna.it
- Recruiting
Ao Padova
Padova
Francesco Corazza, francesco.corazza@aopd.veneto.it
- Recruiting
Nuovo Ospedale Dei Bambini
Parma
Monica Rubini, rubinim@ao.pr.it
- Recruiting
Policlinico San Matteo
Pavia
Thomas Foiadelli, thomas.foiadelli@gmail.com
- Recruiting
Policlinico Pescara
Pescara
Giorgia Carlone, giorgia.carlone@asl.pe.it
- Recruiting
Ospedale Santa Chiara - Cisanello
Pisa
Alessandro Orsini, aorsini.md@gmail.com
- Recruiting
Ospedale San Jacopo
Pistoia, 51100
Francesca Mangiantini, francesca.mangiantini@usl.toscana.it
- Recruiting
Ospedale Civile Santa Maria Degli Angel
Pordenone
Daniele Santori, daniele.santori@asfo.sanita.fvg.it
- Recruiting
Ospedale Santo Stefano
Prato, 59100
Francesca Grisolia, francesca.grisolia@uslcenntro.toscana.it
- Recruiting
Ospedale Infermi
Rimini
Gianluca Vergine, gianluca.vergine@auslromagna.it
- Recruiting
CAV Gemelli
Roma
Maurizio Paolo Soave, centro.antiveleni@policlinicogemelli.it
- Recruiting
Policlinico Gemelli
Roma
Antonio Gatto, antonio.gatto@policlinicogemelli.it
- Recruiting
Ospedale Regina Margherita
Torino
Claudia Bondone, claudiabondone@virgilio.it
- Recruiting
Santa Chiara
Trento
Stefania Ielo, stefania.ielo@apss.tn.it
- Recruiting
Ulss 2 Marca Trevigiana
Treviso
Valentina Brugnarolo, valentina.brugnolaro@aulss2.veneto.it
- Recruiting
Burlo Garofalo
Trieste
Alessandro Amaddeo, alessandro.amaddeo@burlo.trieste.it
- Recruiting
Clinica Pediatrica Udine
Udine
Chiara Pilotto, chiara.pilotto@asufc.sanita.fvg.it
- Recruiting
CAV Veneto
Verona
Giorgio Ricci, centroantiveleno@aovr.veneto.it
- Recruiting
Ospedale Della Donna E Del Bambino
Verona
Pietro Soloni, pietro.soloni@aovr.veneto.it
- Recruiting
Ospedale San Bortolo
Vicenza
Ilaria Tosetto, ilaria.tosetto@aulssl8.veneto.it
About this study
Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.
The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.
Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room).
- Conditions
- Acute Intoxication
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Incidence of intoxication in paediatric children
Subjects will be stratified by age and type of assumed toxic substance. The incidence of intoxication in paediatric children will be measured taking the total number of new cases of intoxication and divided that by the sum of the person-time of the at-risk population.
Measured: through study completion, an average of 1 year
Determination of Prevalence of intoxication in paediatric children
Subjects will be stratified by age and type of assumed toxic substance. The prevalence of intoxication in this population will be measured calculating the number of people in the sample with the characteristic of interest, divided by the total number of people in the sample.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start5 Apr 2023
- Primary completion5 Apr 2033 (estimated)
- Study completion5 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute IntoxicationStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco De Luca, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291649
- Sponsor's protocol ID
- AMIETOX
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Observational Study of Acute Intoxications in Paediatric Age
- ClinicalTrials.gov ID
- NCT06291649
- Acronym / sponsor ID
- AMIETOX
- Conditions
- Acute Intoxication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 5 Apr 2033 (estimated)
- Study completion
- 5 Aug 2033 (estimated)
- First posted
- 4 Mar 2024 (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.
Acute intoxications represent a major public health problem, especially when affect a population such as children, who are vulnerable and at greater risk of unintentional and preventable poisonings.
The primary objective of the study is to assess the epidemiology of acute intoxications in paediatric age with respect to the social and care factors associated with it in order to then implement in the future a better diagnostic-therapeutic management modality on a national level.
Thi is a prospective non-profit multicentre observational cohort study on acute intoxications in the paediatric age, conducted by AMIETOX, aimed at CAVs (Poison Control Centres) and PSPs (Paediatric emergency room).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- subject between 1 month and 16 years that has reportet to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication
Key inclusion criteria (1 listed)
- Subjects between the ages of 1 month and 16 years who report to the PSPs or contact by telephone the CAVs participating in the study with acute intoxication (defined as contact with a substance that is toxic per se or in such quantities as to cause a harmful effect on the body or administered by a route not intended for that substance)
Key exclusion criteria (1 listed)
- not acquired informed consent
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
Determination of Incidence of intoxication in paediatric children
Time frame: through study completion, an average of 1 year
Subjects will be stratified by age and type of assumed toxic substance. The incidence of intoxication in paediatric children will be measured taking the total number of new cases of intoxication and divided that by the sum of the person-time of the at-risk population.
Determination of Prevalence of intoxication in paediatric children
Time frame: through study completion, an average of 1 year
Subjects will be stratified by age and type of assumed toxic substance. The prevalence of intoxication in this population will be measured calculating the number of people in the sample with the characteristic of interest, divided by the total number of people in the sample.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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.
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Intoxication, run by Meyer Children's Hospital IRCCS at 31 sites in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco De Luca (0555662051, marco.deluca@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Incidence of intoxication in paediatric children (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 4 Mar 2024.