Organophosphate PoisoningNCT07777835
Magnesium Sulphate With Atropine and Pralidoxime vs Standard Therapy Alone in Acute Organophosphate Poisoning
A study testing Atropine plus pralidoxime and Atropine and pralidoxime with adjunctive MgSO4 in people with Organophosphate Poisoning, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial summary
Pakistan, being a developing country, is one of the regions with the most cases of organophosphate (OP) poisoning/toxicity. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Organophosphate Poisoning
- What is being tested?
- Atropine plus pralidoxime and Atropine and pralidoxime with adjunctive MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 10 May 2026to 10 Oct 2026
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Adult patients aged between 18 and 50 years
- Confirmed clinical diagnosis of organophosphate poisoning containing insecticide, through the oral route
- Adult patients, or their legally authorized representative, who will provide informed consent to participate in the study
Who cannot join
- Patients with known allergy to MgSO4
- Patients with documented pre-existing renal impairment (Serum creatinine more than 1.5mg/dl)
- Patients with documented pre-existing cardiac impairments (e.g., heart block)
- Pregnant or lactating women
- Confirmed intake of any other drug or poison
- Patients who will be declared dead on arrival or those who expired within 2 hours of presentation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Nishtar Hospital/Medical University
Multan, Punjab Province, 60000
Sana Usman, +923007154668, sunusman0@gmail.com
Arif Mahmood, FCPS, +923008730810, dr_arif_mahmood@yahoo.com
About this study
Official title: Comparison of the Efficacy of Adjunctive Magnesium Sulphate With Standard Atropine and Pralidoxime Therapy vs Standard Therapy Alone in Acute Organophosphate Poisoning
Pakistan, being a developing country, is one of the regions with the most cases of organophosphate (OP) poisoning/toxicity. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. This study is being carried out with the objective of comparing the 15-day all-cause mortality rate and the total cumulative atropine requirement during hospitalization between patients receiving adjunctive magnesium sulphate with standard therapy and those receiving standard therapy alone.
Read the detailed description
The current standard therapy in OP is lacking in managing the Intermediate Syndrome (IMS) and the delayed complications. This deficiency underscores the need for carrying out research to test the efficacy of adjunct compounds in the better management of the toxicity of this deadly substance. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. In a setting where economic instability and a compromised health system put an uneven burden on the shoulders of the patient, introducing a regimen that could possibly reduce the hospital stay and prevent the use of ventilators can be very healthy for the pockets of the government bodies as well as the patient's attendants. Assessing atropine consumption, need for mechanical ventilation, incidence of respiratory failure due to IMS, length of hospital admission, and mortality in the treatment would enable clinicians to recognize whether the adjunctive treatment is efficacious in achieving reasonable outcomes or not.
- Conditions
- Organophosphate Poisoning
- Being tested
- Atropine plus pralidoxime, Atropine and pralidoxime with adjunctive MgSO4
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine plus pralidoximeDrug
Patients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours).
Atropine and pralidoxime with adjunctive MgSO4Drug
Patients will be treated with standard atropine plus pralidoxime therapy alone.
| Study group | Role | What they receive |
|---|---|---|
| Atropine plus pralidoxime with MgSO4-Group | Experimental | Patients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours). Receives: Drug: Atropine plus pralidoxime; Drug: Atropine and pralidoxime with adjunctive MgSO4 |
| Atropine plus pralidoxime-Group | Experimental | Patients will be treated with standard atropine plus pralidoxime therapy alone. Receives: Drug: Atropine plus pralidoxime |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Frequency of patients will be noted who will die within 15 days to clinical stabilization.
Measured: 15 days after hospital admission
Secondary outcomes (1)
Intermediate Syndrome (IMS)
Frequency of patients will be noted who will develop Intermediate Syndrome (IMS) within seven days of poisoning.
Measured: 7 days after poisoning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start10 May 2026
- Primary completion10 Oct 2026 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphate PoisoningStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Sana Usman, Principal investigator, Nishtar Hospital Multan, PakistanArif Mahmood, FCPS, Study director, Nishtar Hospital Multan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777835
- Sponsor's protocol ID
- Dr-Sana-Nishter
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data can be shared on a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Adjunctive Magnesium Sulphate With Standard Atropine and Pralidoxime Therapy vs Standard Therapy Alone in Acute Organophosphate Poisoning
- ClinicalTrials.gov ID
- NCT07777835
- Acronym / sponsor ID
- Dr-Sana-Nishter
- Conditions
- Organophosphate Poisoning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 10 May 2026 (actual)
- Primary completion
- 10 Oct 2026 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 20 Aug 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.
Pakistan, being a developing country, is one of the regions with the most cases of organophosphate (OP) poisoning/toxicity. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. This study is being carried out with the objective of comparing the 15-day all-cause mortality rate and the total cumulative atropine requirement during hospitalization between patients receiving adjunctive magnesium sulphate with standard therapy and those receiving standard therapy alone.
Detailed description
The current standard therapy in OP is lacking in managing the Intermediate Syndrome (IMS) and the delayed complications. This deficiency underscores the need for carrying out research to test the efficacy of adjunct compounds in the better management of the toxicity of this deadly substance. MgSO4 is one of the most promising adjunctive treatments that needs to be tested. In a setting where economic instability and a compromised health system put an uneven burden on the shoulders of the patient, introducing a regimen that could possibly reduce the hospital stay and prevent the use of ventilators can be very healthy for the pockets of the government bodies as well as the patient's attendants. Assessing atropine consumption, need for mechanical ventilation, incidence of respiratory failure due to IMS, length of hospital admission, and mortality in the treatment would enable clinicians to recognize whether the adjunctive treatment is efficacious in achieving reasonable outcomes or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atropine plus pralidoxime with MgSO4-Group | Experimental | Drug: Atropine plus pralidoxime, Drug: Atropine and pralidoxime with adjunctive MgSO4Patients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours). |
| Atropine plus pralidoxime-Group | Experimental | Drug: Atropine plus pralidoximePatients will be treated with standard atropine plus pralidoxime therapy alone. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both genders
- Adult patients aged between 18 and 50 years
- Confirmed clinical diagnosis of organophosphate poisoning containing insecticide, through the oral route
- Adult patients, or their legally authorized representative, who will provide informed consent to participate in the study
Key exclusion criteria (6 listed)
- Patients with known allergy to MgSO4
- Patients with documented pre-existing renal impairment (Serum creatinine more than 1.5mg/dl)
- Patients with documented pre-existing cardiac impairments (e.g., heart block)
- Pregnant or lactating women
- Confirmed intake of any other drug or poison
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 |
|---|---|---|
| Atropine plus pralidoximePatients will be treated with standard atropine and pralidoxime therapy along with adjunctive MgSO4 (loading dose of 4g in 100ml N/S intravenous infusion over 30 minutes, followed by 1g/hr in 100ml N/S continuous IV infusion for 24 hours). | Drug | Atropine plus pralidoxime with MgSO4-Group, Atropine plus pralidoxime-Group |
| Atropine and pralidoxime with adjunctive MgSO4Patients will be treated with standard atropine plus pralidoxime therapy alone. | Drug | Atropine plus pralidoxime with MgSO4-Group |
Primary outcome
Mortality
Time frame: 15 days after hospital admission
Frequency of patients will be noted who will die within 15 days to clinical stabilization.
1 secondary outcome
Intermediate Syndrome (IMS)
Time frame: 7 days after poisoning
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 20 Aug 2026.
- Individual participant dataSharing planned: No. Data can be shared on a reasonable request.
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.
Sana Usman principal investigator
Nishtar Hospital Multan, Pakistan
Arif Mahmood, FCPS study director
Nishtar Hospital Multan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine plus pralidoxime and Atropine and pralidoxime with adjunctive MgSO4 in people with Organophosphate Poisoning, run by Muhammad Aamir Latif at 1 site in Pakistan.
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 4 inclusion and 6 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 20 Aug 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 Pakistan. 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 Sana Usman (+923007154668, sunusman0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 15 days after hospital admission). 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 Aug 2026.