PoisoningIntoxParaNCT04850014
PBPK Modelling Applied to Acetaminophen Poisoned Obese Children
An observational study of Poisoning and Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. Read more about this study
- Who is it for?
- Ages 10 years and older
- What is being tested?
- Anthropomorphism and Relevant clinical datas
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to Oct 2021
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: * Poisoned acetaminophen subjects * At least one acetaminophen blood sample result available in data base
Who may be able to join
- All subjects >/= 10 year old
- Availability of at least one positive acetaminophen concentration with its associated sampling time
- Known clinical outcome
Who cannot join
- < 10 year old
- lack of data-
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon
Lyon, 69000
Kim An NGUYEN, MD, 4 72 31 94 11 ext. +33, kim-an.nguyen@chu-lyon.fr
About this study
Official title: Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children
Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.
- Being tested
- Anthropomorphism, Relevant clinical datas
- Keywords
- PBPK, Modelling, Acetaminophen, Paracetamol, Pediatrics, Obesity, Pharmacokinetics, Toxicokinetics, Poisoning
- Medical subject headings
- Poisoning, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthropomorphismOther
Height, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender
Relevant clinical datasOther
Medical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation.
Imaging.
| Study group | Role | What they receive |
|---|---|---|
| Poisoned patients | All subjects with paracetamolemia in the context of paracetamol poisoning Receives: Other: Anthropomorphism; Other: Relevant clinical datas | |
| Control group | Acetaminophen-poisoned patient being non-obese Receives: Other: Anthropomorphism; Other: Relevant clinical datas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetaminophen concentration
With hour post-ingestion provided
Measured: 31 october 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Jan 2021
- Primary completionMay 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850014
- Sponsor's protocol ID
- 69HCL20_1244
- Acronym
- IntoxPara
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children
- ClinicalTrials.gov ID
- NCT04850014
- Acronym / sponsor ID
- IntoxPara / 69HCL20_1244
- Keywords
- PBPK, Modelling, Acetaminophen, Paracetamol, Pediatrics, Obesity, Pharmacokinetics, Toxicokinetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- May 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 20 Apr 2021 (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.
Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poisoned patients | – | Other: Anthropomorphism, Other: Relevant clinical datasAll subjects with paracetamolemia in the context of paracetamol poisoning |
| Control group | – | Other: Anthropomorphism, Other: Relevant clinical datasAcetaminophen-poisoned patient being non-obese |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * Poisoned acetaminophen subjects * At least one acetaminophen blood sample result available in data base
Key inclusion criteria (3 listed)
- All subjects >/= 10 year old
- Availability of at least one positive acetaminophen concentration with its associated sampling time
- Known clinical outcome
Key exclusion criteria (2 listed)
- < 10 year old
- lack of data-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnthropomorphismHeight, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender | Other | Control group, Poisoned patients |
| Relevant clinical datasMedical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation. Imaging. | Other | Control group, Poisoned patients |
Primary outcome
Acetaminophen concentration
Time frame: 31 october 2021
With hour post-ingestion provided
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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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.
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 Poisoning and Obesity, run by Hospices Civils de Lyon at 1 site in France.
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 20 Apr 2021. 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 France. 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?
Contact Kim An NGUYEN, MD (4 72 31 94 11 ext. +33, kim-an.nguyen@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetaminophen concentration (time frame: 31 october 2021). 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 20 Apr 2021.