Paracetamol ToxicityNCT07454590
Evaluation of Differences Between the Standered NAC Regimen Protocol and the SNAP Regimen Protocol in the Treatment of Paracetamol Toxicity for Cases Presented Early and Late to Assiut University Hospitals in Terms of Safety and Efficiecy.
A study testing Evidence-based medical care for paracetamol toxicity in people with Paracetamol Toxicity, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Paracetamol Toxicity
- What is being tested?
- Evidence-based medical care for paracetamol toxicity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Jun 2027
- Phase
- Interventional
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All cases admitted to Assiut University Hospitals with history of acute paracetamol overdose ingestion .
Who cannot join
- * Co-ingestion of other hepatotoxic drugs .
- Pre-existing liver diseases: Chronic hepatitis B or C, Autoimmune hepatitis, Wilson's disease, Known cirrhosis , Sepsis, shock, or hypoxic injury affecting the liver.
- Hemolytic disorders causing abnormal LFTs.
- Genetic or metabolic diseases that affect liver functions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
marwa khalifa mohmad contact
About this study
Official title: Comparative Study of Twelve Hours Versus Twenty One Hours Protocols of Intravenous N-Acetyl Cystiene Treatment in Paracetamol Toxicity at Assiut University Childern's Hospital
Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy.
Read the detailed description
Acetamenphen is an analgesic and antipyretic drug . It is used as an active ingredient in many over-the-counter and prescription medications. It is generally considered safe at therapeutic doses. However, toxicity can be caused by multiple supratherapeutic doses or an acute, high overdose .
Acetaminophen is metabolized by the cytochrome P450 2E1 to N-acetyl para- benzoquinone-imine (NAPQI), a metabolit extremely toxic to the liver. This process depletes glutathione; thus, NAPQI binds to cellular and mitochondrial proteins to form adducts, impairing mitochondrial respiration and generating oxidative stress .
N-Acetylcysteine (NAC) is a 20-21-hour regimen which involves 3 weight related infusions. The first 150mg/kg is given over 1 hour, second 50mg/kg given over 4 hours and the last 100mg/kg given over 16 hours. This has been the optimal available therapy since 1980 .
Several evidence shows various adverse effect of this regimen which include anaphylactoid reaction, nausea, vomiting and medication error .
Recently the intravenous regimen has been simplified from a three-bag regimen to a two-bag regimen in many parts of the world, which has reduced the early very high concentrations and therefore adverse reaction rate .
Different clinical studies have been carried out to propose the adoption of a shorter regimen, the Scottish and Newcastle Antiemetic Pre-treatment (SNAP) 12-hours NAC regimen into clinical practice .
The SNAP is a two-bag regimen which involves giving 100mg/kg infusion over 2hours, then last 200mg/kg infusion giving over 10hours .
The SNAP regimen confirms that it produces fewer adverse drug reactions (ADRs) and has similar efficacy with regard to preventing liver injury when compared to the 21 h NAC regimen. Further clinical development and adoption of the SNAP regimen could improve treatment safety for this patient group, potentially shorten the length of treatment without compromising antidote effectiveness.
- Conditions
- Paracetamol Toxicity
- Being tested
- Evidence-based medical care for paracetamol toxicity
- Keywords
- paracetamol toxicity, acetaminophen poisoning, N-acetylcysteine, 12 h NAC protocol, 21 h NAC protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based medical care for paracetamol toxicityOther
adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol
Evidence-based medical care for paracetamol toxicityOther
adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol
Evidence-based medical care for paracetamol toxicityOther
adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol
Evidence-based medical care for paracetamol toxicityOther
adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol
| Study group | Role | What they receive |
|---|---|---|
| patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Not described Receives: Other: Evidence-based medical care for paracetamol toxicity |
| patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Not described Receives: Other: Evidence-based medical care for paracetamol toxicity |
| patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Not described Receives: Other: Evidence-based medical care for paracetamol toxicity |
| patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Not described Receives: Other: Evidence-based medical care for paracetamol toxicity |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
1-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment
Measured: 1- Day 2
change in serum creatinine level
Mean change in serum creatinine (mg/dL) from baseline to end of treatment.
Measured: Day 2
Incidence of adverse drug reactions
Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment
Measured: Day 2
Secondary outcomes (2)
rate of clinical recovery
Number of participants who achieve complete clinical recovery without complications
Measured: immediately after the intervention
incidence of serious complications
Number of participants who develop fulminant hepatic failure, hepatic encephalopathy, coma, or hemorrhage.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paracetamol ToxicityStudies of the same condition, open and under way.
- More trials run by Assiut 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabreen Rabee Hasan Mohmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454590
- Sponsor's protocol ID
- TTT of paracetamol toxicity
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13.
PubMed 31311721
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Twelve Hours Versus Twenty One Hours Protocols of Intravenous N-Acetyl Cystiene Treatment in Paracetamol Toxicity at Assiut University Childern's Hospital
- ClinicalTrials.gov ID
- NCT07454590
- Acronym / sponsor ID
- TTT of paracetamol toxicity
- Conditions
- Paracetamol Toxicity
- Keywords
- paracetamol toxicity, acetaminophen poisoning, N-acetylcysteine, 12 h NAC protocol, 21 h NAC protocol
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 6 Mar 2026 (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.
Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy.
Detailed description
Acetamenphen is an analgesic and antipyretic drug . It is used as an active ingredient in many over-the-counter and prescription medications. It is generally considered safe at therapeutic doses. However, toxicity can be caused by multiple supratherapeutic doses or an acute, high overdose .
Acetaminophen is metabolized by the cytochrome P450 2E1 to N-acetyl para- benzoquinone-imine (NAPQI), a metabolit extremely toxic to the liver. This process depletes glutathione; thus, NAPQI binds to cellular and mitochondrial proteins to form adducts, impairing mitochondrial respiration and generating oxidative stress .
N-Acetylcysteine (NAC) is a 20-21-hour regimen which involves 3 weight related infusions. The first 150mg/kg is given over 1 hour, second 50mg/kg given over 4 hours and the last 100mg/kg given over 16 hours. This has been the optimal available therapy since 1980 .
Several evidence shows various adverse effect of this regimen which include anaphylactoid reaction, nausea, vomiting and medication error .
Recently the intravenous regimen has been simplified from a three-bag regimen to a two-bag regimen in many parts of the world, which has reduced the early very high concentrations and therefore adverse reaction rate .
Different clinical studies have been carried out to propose the adoption of a shorter regimen, the Scottish and Newcastle Antiemetic Pre-treatment (SNAP) 12-hours NAC regimen into clinical practice .
The SNAP is a two-bag regimen which involves giving 100mg/kg infusion over 2hours, then last 200mg/kg infusion giving over 10hours .
The SNAP regimen confirms that it produces fewer adverse drug reactions (ADRs) and has similar efficacy with regard to preventing liver injury when compared to the 21 h NAC regimen. Further clinical development and adoption of the SNAP regimen could improve treatment safety for this patient group, potentially shorten the length of treatment without compromising antidote effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Other: Evidence-based medical care for paracetamol toxicity |
| patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Other: Evidence-based medical care for paracetamol toxicity |
| patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Other: Evidence-based medical care for paracetamol toxicity |
| patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity | Active comparator | Other: Evidence-based medical care for paracetamol toxicity |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All cases admitted to Assiut University Hospitals with history of acute paracetamol overdose ingestion .
Key exclusion criteria (4 listed)
- * Co-ingestion of other hepatotoxic drugs .
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 |
|---|---|---|
| Evidence-based medical care for paracetamol toxicityadminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol | Other | patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity |
| Evidence-based medical care for paracetamol toxicityadminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol | Other | patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity |
| Evidence-based medical care for paracetamol toxicityadminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol | Other | patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity |
| Evidence-based medical care for paracetamol toxicityadminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol | Other | patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity |
Primary outcome
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
Time frame: 1- Day 2
1-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment
change in serum creatinine level
Time frame: Day 2
Mean change in serum creatinine (mg/dL) from baseline to end of treatment.
Incidence of adverse drug reactions
Time frame: Day 2
Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment
2 secondary outcomes
rate of clinical recovery
Time frame: immediately after the intervention
incidence of serious complications
Time frame: immediately after the intervention
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 6 Mar 2026.
- Background: PubMed 31311721Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13.
- Safety and Efficacy of the SNAP 12-hour Acetylcysteine Regimen for the Treatment of Paracetamol OverdoseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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.
marwa khalifa mohmad contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based medical care for paracetamol toxicity in people with Paracetamol Toxicity, run by Assiut University at 1 site in Egypt.
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 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: opening soon, as of the sponsor's last update on 6 Mar 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 Egypt. 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 sabreen rabee hasan (00201141586524, Sabreenrabee1998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (time frame: 1- Day 2). 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?
On the ClinicalTrials.gov record for NCT07454590, which also lists 1 linked publication.
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 6 Mar 2026.