Organophosphorus PoisoningPhase 2OPCNCT06111352
Outcome of Moderate Severity in OPC Poisoning Patients When Treated With Pralidoxime
A Phase 2 study testing Pralidoxime and Atropine in people with Organophosphorus Poisoning, run by Sir Salimullah Medical College Mitford Hospital at 1 site in Bangladesh.
Trial summary
This open level randomized controlled trial will be conducted in the department of medicine at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history of organophosphorus poisoning within 24… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Organophosphorus Poisoning
- What is being tested?
- Pralidoxime and Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jun 2022to 30 Sep 2023
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient having history of organophosphorus poisoning within 24 hours with features of moderate severity. (POP scale score 4-7)
- Age above 12 years
Who cannot join
- Mixed poisons along with organophosphorus compound,
- Patients with known case chronic diseases such as chronic lung disease, chronic kidney disease, Heart failure, malignancy, chronic liver disease
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Sir Salimullah Medical College Mitford Hospital
Dhaka, 1100
About this study
Official title: Outcome of OPC Poisoning Patients Between Two Treatment Groups One With Atropine Plus Pralidoxime and Other With Only Atropine
This open level randomized controlled trial will be conducted in the department of medicine at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history of organophosphorus poisoning within 24 hours with clinical features and physical evidence of poisoning consumed. Only moderate severity (POP Scale score 4-7) of OPC (Organophosphorus compound) patients will be included in this study. Then one group of patients will be treated with atropine and pralidoxime and another group will be treated with atropine. The outcome will be noted as clinical improvement or recovery. hospital stay, requirement of ICU, death.
Read the detailed description
OPC poisoning is one of the most medical emergencies manage in hospital in our country. For the treatment of this acute cases, along with the supportive measures, intravenous anticholinergic atropine is the mostly used antidote. WHO (World Health Organization) recommended the use of intravenous pralidoxime along with atropine for favorable outcomes, while several studies had doubted effectiveness of its use for the treatment of OPC poisoning. Therefore, the aim of this study is assessment of the outcomes of patients with OPC poisoning of moderate severity between two treatment groups one will be treated with atropine plus Pralidoxime and other with only atropine. This open level randomized controlled trail will be conducted in department of Medicine, Sir Salimullah Medical College \& Mitford Hospital, Dhaka. All the patient admitted in the hospital during the study period with OPC poisoning will be evaluated by clinical presentation. Form the total patients, those patients with the history of organophosphorus poisoning within previous 24 hours with clinical features of poison consumption with moderate severity after assessing by Peradeniya OP (POP) Scale and considering the inclusion and exclusion criteria; participant/patients will be enrolled in the study. A total 96 patients will be enrolled in the study. After inclusion in the study the participant will be randomly allocated following simple randomization technique in both treatment group [atropine plus pralidoxime group (Group A) and atropine only group (Group B). The nature of the chemical composition of the organophosphorus compound will be identified from the brought sample.
The patients of group (A) will be treated with atropine plus pralidoxime and all the patients of group (B) will be treated with atropine only. All patients will receive other supportive therapy with stomach wash, i.v. fluid, antibiotics, and O2 inhalation as required. Every patient will be followed up by careful clinical examination. Patients developing respiratory failure will be identified by clinical examination and by using pulse oximetry. These Patients will be treated in ICU of Sir Salimullah Medical College \& Mitford Hospital and assisted ventilation support will be given. Both groups will be further analyzed from the start of poisoning to arrival at hospital and up to recovery/ ICU support/Death.
Each ampoule of inj atropine contained 0.6 mg atropine sulphate and each vial of inj. pralidoxime contained pralidoxime 1gm. Both drugs will be used in iv route. Inj. pralidoxime will be given as intravenous infusion over 4 minutes to avoid hypotension. Both antidotes will be administered as per recommended dosage schedule.
Inj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then the dose will be doubled from the previous dose in every 5 minutes interval until the signs of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was given until the signs of atropinisation appeared) per hour, will be given with intravenous Normal saline/ 5% DNS(Dextrose and Sodium chloride infusion) as a maintenance dose. The dose will be reduced for adjustment, based on clinical features/improvement. Inj. Pralidoxime 1 gm I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness, then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an 8-hour interval. The atropine and pralidoxime dose will be continued until symptomatic improvement and recovery. After discontinue of antidote further patient will be observed 24-48 hours then patient will be discharge. Study outcomes will provide any benefit of pralidoxime in moderately severe OPC poisoning patients.
- Conditions
- Organophosphorus Poisoning
- Being tested
- Pralidoxime, Atropine
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PralidoximeDrug
Inj. Pralidoxime 1 gm I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness, then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an 8-hour interval
AtropineDrug
Inj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then the dose will be doubled from the previous dose in every 5 minutes interval until the signs of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was given until the signs of atropinisation appeared) per hour, will be given with intravenous Normal saline/ 5% DNS(Dextrose and Sodium chloride) as a maintenance dose. The dose will be reduced for adjustment, based on clinical features/improvement
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Patients will be treated with Atropine plus pralidoxime
Pralidoxime: Dosage:1gram; Dosage form: Intravenous infusion; Frequency: 8 hourly
Atropine: Receives: Drug: Pralidoxime; Drug: Atropine |
| Group B | Other | Patients will be treated with only atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate
Measured: 1 year
Secondary outcomes (1)
Proportion of patients who required intubation
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 posted1 Nov 2023
- Study start1 Jun 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organophosphorus 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open level, Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sir Salimullah Medical College Mitford Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Md. Mahmudul Hasan, Sir Salimullah Medical College Mitford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111352
- Sponsor's protocol ID
- 59.18.1100.031.18.011.22.2268
- Acronym
- OPC
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2023
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I have some resource problem.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of OPC Poisoning Patients Between Two Treatment Groups One With Atropine Plus Pralidoxime and Other With Only Atropine
- ClinicalTrials.gov ID
- NCT06111352
- Acronym / sponsor ID
- OPC / 59.18.1100.031.18.011.22.2268
- Conditions
- Organophosphorus Poisoning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sir Salimullah Medical College Mitford HospitalOther government
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 1 Nov 2023 (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.
This open level randomized controlled trial will be conducted in the department of medicine at Sir Salimullah Medical College and Mitford Hospital. Clinical severity will be assessed by the POP (Peradeniya Organophosphorus Poisoning) scale of admitted patients having a history of organophosphorus poisoning within 24 hours with clinical features and physical evidence of poisoning consumed. Only moderate severity (POP Scale score 4-7) of OPC (Organophosphorus compound) patients will be included in this study. Then one group of patients will be treated with atropine and pralidoxime and another group will be treated with atropine. The outcome will be noted as clinical improvement or recovery. hospital stay, requirement of ICU, death.
Detailed description
OPC poisoning is one of the most medical emergencies manage in hospital in our country. For the treatment of this acute cases, along with the supportive measures, intravenous anticholinergic atropine is the mostly used antidote. WHO (World Health Organization) recommended the use of intravenous pralidoxime along with atropine for favorable outcomes, while several studies had doubted effectiveness of its use for the treatment of OPC poisoning. Therefore, the aim of this study is assessment of the outcomes of patients with OPC poisoning of moderate severity between two treatment groups one will be treated with atropine plus Pralidoxime and other with only atropine. This open level randomized controlled trail will be conducted in department of Medicine, Sir Salimullah Medical College \& Mitford Hospital, Dhaka. All the patient admitted in the hospital during the study period with OPC poisoning will be evaluated by clinical presentation. Form the total patients, those patients with the history of organophosphorus poisoning within previous 24 hours with clinical features of poison consumption with moderate severity after assessing by Peradeniya OP (POP) Scale and considering the inclusion and exclusion criteria; participant/patients will be enrolled in the study. A total 96 patients will be enrolled in the study. After inclusion in the study the participant will be randomly allocated following simple randomization technique in both treatment group [atropine plus pralidoxime group (Group A) and atropine only group (Group B). The nature of the chemical composition of the organophosphorus compound will be identified from the brought sample.
The patients of group (A) will be treated with atropine plus pralidoxime and all the patients of group (B) will be treated with atropine only. All patients will receive other supportive therapy with stomach wash, i.v. fluid, antibiotics, and O2 inhalation as required. Every patient will be followed up by careful clinical examination. Patients developing respiratory failure will be identified by clinical examination and by using pulse oximetry. These Patients will be treated in ICU of Sir Salimullah Medical College \& Mitford Hospital and assisted ventilation support will be given. Both groups will be further analyzed from the start of poisoning to arrival at hospital and up to recovery/ ICU support/Death.
Each ampoule of inj atropine contained 0.6 mg atropine sulphate and each vial of inj. pralidoxime contained pralidoxime 1gm. Both drugs will be used in iv route. Inj. pralidoxime will be given as intravenous infusion over 4 minutes to avoid hypotension. Both antidotes will be administered as per recommended dosage schedule.
Inj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then the dose will be doubled from the previous dose in every 5 minutes interval until the signs of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was given until the signs of atropinisation appeared) per hour, will be given with intravenous Normal saline/ 5% DNS(Dextrose and Sodium chloride infusion) as a maintenance dose. The dose will be reduced for adjustment, based on clinical features/improvement. Inj. Pralidoxime 1 gm I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness, then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an 8-hour interval. The atropine and pralidoxime dose will be continued until symptomatic improvement and recovery. After discontinue of antidote further patient will be observed 24-48 hours then patient will be discharge. Study outcomes will provide any benefit of pralidoxime in moderately severe OPC poisoning patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open level, Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Pralidoxime, Drug: AtropinePatients will be treated with Atropine plus pralidoxime Pralidoxime: Dosage:1gram; Dosage form: Intravenous infusion; Frequency: 8 hourly Atropine: |
| Group B | Other | Drug: AtropinePatients will be treated with only atropine |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient having history of organophosphorus poisoning within 24 hours with features of moderate severity. (POP scale score 4-7)
- Age above 12 years
Key exclusion criteria (2 listed)
- Mixed poisons along with organophosphorus compound,
- Patients with known case chronic diseases such as chronic lung disease, chronic kidney disease, Heart failure, malignancy, chronic liver disease
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 |
|---|---|---|
| PralidoximeInj. Pralidoxime 1 gm I/V will be given as first dose over 10-20 minutes. If no improvement of muscle weakness, then repeat the dose after one hour. Then 1 gram of Inj. Pralidoxime will be given at an 8-hour interval | Drug | Group A |
| AtropineInj. Atropine (3 ampule) will be given in intravenous route as a first dose, rapidly. Then the dose will be doubled from the previous dose in every 5 minutes interval until the signs of atropinisation appeared. Then infusion of 10% of the total bolus dose (the dose that was given until the signs of atropinisation appeared) per hour, will be given with intravenous Normal saline/ 5% DNS(Dextrose and Sodium chloride) as a maintenance dose. The dose will be reduced for adjustment, based on clinical features/improvement | Drug | Group A, Group B |
Primary outcome
Mortality rate
Time frame: 1 year
1 secondary outcome
Proportion of patients who required intubation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No. I have some resource problem.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pralidoxime and Atropine in people with Organophosphorus Poisoning, run by Sir Salimullah Medical College Mitford Hospital at 1 site in Bangladesh.
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 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: finished, as of the sponsor's last update on 9 Oct 2024. 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 Bangladesh. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate (time frame: 1 year). 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 9 Oct 2024.