the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ DamagePhase 4NCT04509258
Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning
A Phase 4 study testing N-acetyl cysteine, acetyl L-carnitine and medicated paraffin oil in people with the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage, run by Cairo University at 1 site in Egypt.
Trial summary
Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage
- What is being tested?
- N-acetyl cysteine, acetyl L-carnitine and medicated paraffin oil
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Dec 2021
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study
Who cannot join
- Patients less than 18
- Patients presented with delay time exceeding 12 hours after acute intoxication.
- Patients with history of cardiac, renal or hepatic diseases.
- Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Poison Control Center of Ain-Shams University hospitals
Cairo, Abbasya, 11311
Walaa Abdel Hamid, PhD, +201062261010, walaa.abdelhamid@gmail.com
Dalia Zaafar, PhD, +201117922833, dr.moda88@gmail.com
About this study
Official title: Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial
Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.
- Being tested
- N-acetyl cysteine, acetyl L-carnitine, medicated paraffin oil, Sodium Bicarbonate Powder and ondansetron
- Keywords
- N-acetyl cysteine, Acety L- carnitine, paraffin oil, aluminium phosphide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
a drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care
acetyl L-carnitineDietary supplement
Naturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care
medicated paraffin oilDrug
refined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care
Sodium Bicarbonate Powder and ondansetronDrug
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines Receives: Drug: Sodium Bicarbonate Powder and ondansetron |
| N- acetyl cysteine grouo | Active comparator | N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines Receives: Drug: N-acetyl cysteine; Drug: Sodium Bicarbonate Powder and ondansetron |
| Acetyl L-carnitine group | Active comparator | Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided Receives: Dietary Supplement: acetyl L-carnitine; Drug: Sodium Bicarbonate Powder and ondansetron |
| Medicated paraffin oil group | Active comparator | Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines Receives: Drug: medicated paraffin oil; Drug: Sodium Bicarbonate Powder and ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate reduction
the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets
Measured: 1 year
organ damage reduction
another primary end point is to reduce organ damage and injury for survivors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ DamageStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Dalia K. Zaafar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509258
- Sponsor's protocol ID
- R 66/2019
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04509258
- Acronym / sponsor ID
- R 66/2019
- Keywords
- N-acetyl cysteine, Acety L- carnitine, paraffin oil, aluminium phosphide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 12 Aug 2020 (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.
Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Sodium Bicarbonate Powder and ondansetronthis group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines |
| N- acetyl cysteine grouo | Active comparator | Drug: N-acetyl cysteine, Drug: Sodium Bicarbonate Powder and ondansetronN-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines |
| Acetyl L-carnitine group | Active comparator | Dietary Supplement: acetyl L-carnitine, Drug: Sodium Bicarbonate Powder and ondansetronAcetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided |
| Medicated paraffin oil group | Active comparator | Drug: medicated paraffin oil, Drug: Sodium Bicarbonate Powder and ondansetronGastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study
Key exclusion criteria (4 listed)
- Patients less than 18
- Patients presented with delay time exceeding 12 hours after acute intoxication.
- Patients with history of cardiac, renal or hepatic diseases.
- Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.
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 |
|---|---|---|
| N-acetyl cysteinea drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care | Drug | N- acetyl cysteine grouo |
| acetyl L-carnitineNaturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care | Dietary supplement | Acetyl L-carnitine group |
| medicated paraffin oilrefined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care | Drug | Medicated paraffin oil group |
| Sodium Bicarbonate Powder and ondansetronstandard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide | Drug | Acetyl L-carnitine group, Medicated paraffin oil group, N- acetyl cysteine grouo, control group |
Primary outcome
mortality rate reduction
Time frame: 1 year
the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets
organ damage reduction
Time frame: 1 year
another primary end point is to reduce organ damage and injury for survivors
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Individual participant dataSharing planned: No. individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names
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?
A Phase 4 study testing N-acetyl cysteine, acetyl L-carnitine and medicated paraffin oil in people with the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage, run by Cairo 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: status not confirmed, as of the sponsor's last update on 12 Aug 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Sakr, PhD (+201117922833, mahmoud.sakr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate reduction (time frame: 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 12 Aug 2020.