Charcoal, Decontamination, PoisoningPhase 4CHARPP-PilotNCT05471479
Activated CHARcoal in Poisoned Patient - Pilot Trial
A Phase 4 study testing Activated Charcoal and No activated charcoal in people with Charcoal, Decontamination, Poisoning, run by Laval University at 1 site in Canada.
Trial summary
The goal of this clinical pilot trial is to determine the feasibility of the clinical trial. Then the large-scale CHARPP will be conducted in order to determine the efficacity of activated charcoal as a treatment for acute poisoning in a diverse population of both adults and children suspected of ingesting toxic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Charcoal, Decontamination, Poisoning
- What is being tested?
- Activated Charcoal and No activated charcoal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jul 2025to 1 Feb 2027
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult and pediatric patients who presented to the hospital less than 6h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance (substance adsorbed by activated charcoal ).
- Patients who can receive the intervention within 6 hours of proven or suspected intoxication
Who cannot join
- Patients requiring or who will likely require another gastro-intestinal decontamination method;
- Patients who have contraindication to the use of activated charcoal;
- Patients who ingested a substance with an entero-hepatic circulation requiring multi-dose AC;
- Patients who have no clinical equipoise for the use of activated charcoal as per the attending physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1J1Z4
Maude St-Onge, Md PhD FRCPC, 418-932-5357, maude.st-onge.med@ssss.gouv.qc.ca
Audrée Elliott, BPharm, MSc, 418-573-8799, audree.elliott.ciusscn@ssss.gouv.qc.ca
About this study
Official title: CHARPP (Activated CHARcoal in Poisoned Patient): RCT Pilot Study
The goal of this clinical pilot trial is to determine the feasibility of the clinical trial. Then the large-scale CHARPP will be conducted in order to determine the efficacity of activated charcoal as a treatment for acute poisoning in a diverse population of both adults and children suspected of ingesting toxic substances that activated charcoal can adsorb. The main questions it aims to answer are:
- Can activated charcoal administered within a specific time frame prevent the progression of toxicity?
- How does activated charcoal affect the length of stay in the hospital and the intensive care unit? Researchers will compare the intervention arm (receiving activated charcoal) to the control arm (receiving standard supportive care) to see if activated charcoal reduces hospital stay duration, ICU stay and improves overall patient outcomes.
Read more
Participants will:
- Be randomly assigned to either receive activated charcoal or standard supportive care.
- Undergo assessments using standardized clinical scales such as the Poison Severity Score and, for children, the PELODS score.
- Have their functional outcomes evaluated, such as the ability to return to their original residence without help and manage personal hygiene tasks independently.
This structured approach will help clarify the role of activated charcoal in clinical toxicology and inform future treatment protocols.
Read the detailed description
BACKGROUND: Activated charcoal (AC) is one of the interventions more frequently recommended by poison centers. For instance, in 2020, 32,646 poisoned patients were treated with AC in the United States. This decontamination method has the potential to prevent toxicity and to decrease its severity, but its use is also associated with adverse effects and has a poor palatability. Therefore, we developed a research program named CHARPP (activated CHARcoal in Poisoned Patients) aiming to describe the effect and potential risks associated with the use of AC. This study is particularly focused on whether early administration of activated charcoal can reduce the severity of poisoning outcomes, shorten hospital stays, and mitigate healthcare costs.The first phase of our research program included: a retrospective study and a validation of the Poison Severity Score. The last phase includes a randomized controlled trial (RCT) preceded by a feasibility study in adults and children to compare outcomes in patients who received AC vs those who did not.
OBJECTIVES: This concerns the CHARPP RCT feasibility study which aims to evaluate the possibility of conducting a large multicenter RCT comparing outcomes between poisoned patients who received AC and who did not received AC. The targeted primary outcomes includes: 1) recruitment success (100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month), 2) protocol adherence (at least 85% of the patient randomized in the intervention group received AC in less than two hours after group allocation if AC was recommended or did not received it if it was not recommended) and, 3) Less than 5% loss to follow-up. As for the large-scale clinical trial if pilot trial shows feasability, the primary outcome will be progression of toxicity as measured using the Poison Severity Score, a patient-oriented metric frequently used in toxicology; mortality, length of stay in both the intensive care unit and hospital, quality of life as measured by the EQ-5D-5L, and changes in the SOFA score for adults and the PELODS score for children.
METHODS: This randomized concealed multicenter trial will take place in one poison centre and five academic hospitals within the provincial network of the centre antipoison du Québec. Patients presenting to the Emergency rooms with a proven or suspected ingestion of a substance absorbed by activated charcoal and the ones who can receive the intervention within 6 hours of proven or suspected intoxication will be included. Patients requiring or who will likely require another gastro-intestinal decontamination method, who have a contraindication to receive AC, or who ingested a substance with an entero-hepatic circulation requiring multi-dose AC will be excluded. Once the poison centre has identified an eligible patient, we will use a web-based system to perform a randomization in random blocks of two or four. Co-interventions will be standardized as per the poison centre protocols. Follow up will be done every 8h by the poison centres who will also collect data regarding progression of toxicity and relevant outcomes. The research assistant who will extract data will be blinded to study allocation. Only a descriptive analysis will be done for the pilot trial. Data from paediatric patients will be analysed separately. A data and safety monitoring board independent from the study group will follow the results and approve or not the continuation of the study.
RELEVANCE: This will be an excellent opportunity to develop collaborations between poison centers and key actors who will be involved in a larger trial. The results of the research program CHARPP have the potential to influence policies, poison centers recommendations, clinicians' practices and to improve poisoned patients' outcomes.
- Conditions
- Charcoal, Decontamination, Poisoning
- Being tested
- Activated Charcoal, No activated charcoal
- Keywords
- activated charcoal, decontamination, poisoning, intoxication, toxicity, clinical trial, toxicology, Emergency medicine, PROBE trial
- Medical subject headings
- Anthrax, Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activated CharcoalDrug
Also called AC
Activated charcoal
No activated charcoalOther
No activated charcoal
| Study group | Role | What they receive |
|---|---|---|
| AC administration | Experimental | Participants will receive 1g/kg up to a maximum of 50g of activated charcoal by mouth or by naso-gastric tube. The intervention is giving over 15 minutes, as recommended. Activated charcoal can be mixed in a black soft drink to improve palatability and treatment adherence which is often done in usual practice. Receives: Drug: Activated Charcoal |
| No AC | Active comparator | Participants will not receive any activated charcoal Receives: Other: No activated charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment success
100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month
Measured: 12 months
Protocol adherence
at least 85% of the patient randomized in the intervention group
Measured: 12 months
lost to follow-up
less than 5%
Measured: 12 months
Secondary outcomes (6)
Progression of toxicity (descriptive measure of delta Poison Severity Score - PSS max - PSS at randomization calculated at the end of each case)
measured by the delta Poison Severity Score (min = 0 - better outcome; max = 4 - worse outcome) (and the SOFA - sequential organ failure assessment - score for adults or PELOD -paediatric logistic organ dysfunction - score for children) and available drug levels
Measured: 3 months
Mortality
Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator
Measured: 3 months
Length of stay in the intensive care unit and hospital
Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator
Measured: 3 months
Duration of mechanical ventilation
Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator
Measured: 3 months
functional outcomes (descriptive measure: "back to baseline" or "not back to baseline" calculated at the moment of medical discharge, death or decision of withdrawal of life support)
The ability of patients to return to their daily lives and activities after treatment. Specifically, the trial looks at whether patients can return to their original residence without help and manage personal hygiene tasks such as toileting independently. Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator
Measured: 6 months
adverse events
Will be documented by both the poison centre and the hospitals. Will be collected in by the research coordinator
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start16 Jul 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Charcoal, Decontamination, PoisoningStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The CHARPP pilot trial employs a Prospective Randomized Open Blinded End-point (PROBE) interventional study model. The study is designed to follow participants forward in time after their enrollment, with interventions and outcomes measured as they occur. Participants are randomly assigned to either the intervention group, which receives activated charcoal, or the control group, which does not receive activated charcoal. This randomization helps to minimize selection bias and balance known and unknown confounding factors across the study groups. The nature of the intervention (activated charcoal) makes it impractical to blind the participants or the clinicians administering the treatment, as the substance visibly changes the color of the oral mucosa to black. While the immediate caregivers and participants know the treatment allocation due to the visible nature of activated charcoal, the outcome assessors and data analysts are blinded to the group assignment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), VITAM - Centre de recherche en santé durable, CHU de Quebec-Universite Laval
- Responsible party
- Principal investigator, Maude St-Onge, Laval University
- Investigators
- Maude St-Onge, MD PhD FRCPC, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471479
- Sponsor's protocol ID
- CHARPP - pilot study
- Acronym
- CHARPP-Pilot
- Status last verified
- Mar 2025
- First submitted
- 14 Jul 2022
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHARPP (Activated CHARcoal in Poisoned Patient): RCT Pilot Study
- ClinicalTrials.gov ID
- NCT05471479
- Acronym / sponsor ID
- CHARPP-Pilot / CHARPP - pilot study
- Conditions
- Charcoal, Decontamination, Poisoning
- Keywords
- activated charcoal, decontamination, poisoning, intoxication, toxicity, clinical trial, toxicology, Emergency medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), VITAM - Centre de recherche en santé durable, CHU de Quebec-Universite Laval
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 22 Jul 2022 (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.
The goal of this clinical pilot trial is to determine the feasibility of the clinical trial. Then the large-scale CHARPP will be conducted in order to determine the efficacity of activated charcoal as a treatment for acute poisoning in a diverse population of both adults and children suspected of ingesting toxic substances that activated charcoal can adsorb. The main questions it aims to answer are:
- Can activated charcoal administered within a specific time frame prevent the progression of toxicity?
- How does activated charcoal affect the length of stay in the hospital and the intensive care unit? Researchers will compare the intervention arm (receiving activated charcoal) to the control arm (receiving standard supportive care) to see if activated charcoal reduces hospital stay duration, ICU stay and improves overall patient outcomes.
Participants will:
- Be randomly assigned to either receive activated charcoal or standard supportive care.
- Undergo assessments using standardized clinical scales such as the Poison Severity Score and, for children, the PELODS score.
- Have their functional outcomes evaluated, such as the ability to return to their original residence without help and manage personal hygiene tasks independently.
This structured approach will help clarify the role of activated charcoal in clinical toxicology and inform future treatment protocols.
Detailed description
BACKGROUND: Activated charcoal (AC) is one of the interventions more frequently recommended by poison centers. For instance, in 2020, 32,646 poisoned patients were treated with AC in the United States. This decontamination method has the potential to prevent toxicity and to decrease its severity, but its use is also associated with adverse effects and has a poor palatability. Therefore, we developed a research program named CHARPP (activated CHARcoal in Poisoned Patients) aiming to describe the effect and potential risks associated with the use of AC. This study is particularly focused on whether early administration of activated charcoal can reduce the severity of poisoning outcomes, shorten hospital stays, and mitigate healthcare costs.The first phase of our research program included: a retrospective study and a validation of the Poison Severity Score. The last phase includes a randomized controlled trial (RCT) preceded by a feasibility study in adults and children to compare outcomes in patients who received AC vs those who did not.
OBJECTIVES: This concerns the CHARPP RCT feasibility study which aims to evaluate the possibility of conducting a large multicenter RCT comparing outcomes between poisoned patients who received AC and who did not received AC. The targeted primary outcomes includes: 1) recruitment success (100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month), 2) protocol adherence (at least 85% of the patient randomized in the intervention group received AC in less than two hours after group allocation if AC was recommended or did not received it if it was not recommended) and, 3) Less than 5% loss to follow-up. As for the large-scale clinical trial if pilot trial shows feasability, the primary outcome will be progression of toxicity as measured using the Poison Severity Score, a patient-oriented metric frequently used in toxicology; mortality, length of stay in both the intensive care unit and hospital, quality of life as measured by the EQ-5D-5L, and changes in the SOFA score for adults and the PELODS score for children.
METHODS: This randomized concealed multicenter trial will take place in one poison centre and five academic hospitals within the provincial network of the centre antipoison du Québec. Patients presenting to the Emergency rooms with a proven or suspected ingestion of a substance absorbed by activated charcoal and the ones who can receive the intervention within 6 hours of proven or suspected intoxication will be included. Patients requiring or who will likely require another gastro-intestinal decontamination method, who have a contraindication to receive AC, or who ingested a substance with an entero-hepatic circulation requiring multi-dose AC will be excluded. Once the poison centre has identified an eligible patient, we will use a web-based system to perform a randomization in random blocks of two or four. Co-interventions will be standardized as per the poison centre protocols. Follow up will be done every 8h by the poison centres who will also collect data regarding progression of toxicity and relevant outcomes. The research assistant who will extract data will be blinded to study allocation. Only a descriptive analysis will be done for the pilot trial. Data from paediatric patients will be analysed separately. A data and safety monitoring board independent from the study group will follow the results and approve or not the continuation of the study.
RELEVANCE: This will be an excellent opportunity to develop collaborations between poison centers and key actors who will be involved in a larger trial. The results of the research program CHARPP have the potential to influence policies, poison centers recommendations, clinicians' practices and to improve poisoned patients' outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The CHARPP pilot trial employs a Prospective Randomized Open Blinded End-point (PROBE) interventional study model. The study is designed to follow participants forward in time after their enrollment, with interventions and outcomes measured as they occur. Participants are randomly assigned to either the intervention group, which receives activated charcoal, or the control group, which does not receive activated charcoal. This randomization helps to minimize selection bias and balance known and unknown confounding factors across the study groups. The nature of the intervention (activated charcoal) makes it impractical to blind the participants or the clinicians administering the treatment, as the substance visibly changes the color of the oral mucosa to black. While the immediate caregivers and participants know the treatment allocation due to the visible nature of activated charcoal, the outcome assessors and data analysts are blinded to the group assignment.
| Arm | Type | Receives |
|---|---|---|
| AC administration | Experimental | Drug: Activated CharcoalParticipants will receive 1g/kg up to a maximum of 50g of activated charcoal by mouth or by naso-gastric tube. The intervention is giving over 15 minutes, as recommended. Activated charcoal can be mixed in a black soft drink to improve palatability and treatment adherence which is often done in usual practice. |
| No AC | Active comparator | Other: No activated charcoalParticipants will not receive any activated charcoal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult and pediatric patients who presented to the hospital less than 6h after the ingestion of a potentially toxic dose of a carbo-adsorbable substance (substance adsorbed by activated charcoal ).
- Patients who can receive the intervention within 6 hours of proven or suspected intoxication
Key exclusion criteria (4 listed)
- Patients requiring or who will likely require another gastro-intestinal decontamination method;
- Patients who have contraindication to the use of activated charcoal;
- Patients who ingested a substance with an entero-hepatic circulation requiring multi-dose AC;
- Patients who have no clinical equipoise for the use of activated charcoal as per the attending physician.
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 |
|---|---|---|
| Activated CharcoalAlso: ACActivated charcoal | Drug | AC administration |
| No activated charcoalNo activated charcoal | Other | No AC |
Primary outcome
Recruitment success
Time frame: 12 months
100 patients total at the poison centre associated with hospitals and greater than one patient enrolled/hospital/month
Protocol adherence
Time frame: 12 months
at least 85% of the patient randomized in the intervention group
lost to follow-up
Time frame: 12 months
less than 5%
6 secondary outcomes
Progression of toxicity (descriptive measure of delta Poison Severity Score - PSS max - PSS at randomization calculated at the end of each case)
Time frame: 3 months
Mortality
Time frame: 3 months
Length of stay in the intensive care unit and hospital
Time frame: 3 months
Duration of mechanical ventilation
Time frame: 3 months
functional outcomes (descriptive measure: "back to baseline" or "not back to baseline" calculated at the moment of medical discharge, death or decision of withdrawal of life support)
Time frame: 6 months
adverse events
Time frame: 3 months
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 29 Jan 2026.
- Individual participant dataSharing planned: Yes. Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code
Related trials for Charcoal, Decontamination, Poisoning
RecruitingPhase 2
Combined Gastrointestinal Decontamination in Acute Severe Poisoning
Severe Poisoning With Cardiotropic or Psychotropic Drug, Admission to Intensive Care
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.
Maude St-Onge, MD PhD FRCPC principal investigator
CHU de Québec - Université Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Activated Charcoal and No activated charcoal in people with Charcoal, Decontamination, Poisoning, run by Laval University at 1 site in Canada.
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 2 inclusion and 4 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 29 Jan 2026. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Maude St-Onge, MD PhD FRCPC (418-932-5357, maude.st-onge.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment success (time frame: 12 months). The study lists 3 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 29 Jan 2026.