Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

Pesticide Poisoning Clinical Trial

— CCBOC  

Official title:

Effectiveness of Calcium Channel Blockade for Organophosphorus and Carbamate Pesticide Poisoning - an Open, Pragmatic, 3-arm RCT Repurposing Two Widely Available Licensed Medicines

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03925025
• Other study ID #: AC19003
• Status: Recruiting
• Phase: Phase 3
• Start date: December 11, 2020
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: University of Edinburgh
• Contact: Michael Eddleston, ScD
• Phone: 01312426776
• Email: m.eddleston[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates whether the addition of intravenous magnesium sulphate or nimodipine to standard therapy (supportive care plus for all patients atropine and, for OP insecticide poisoned patients, pralidoxime) benefits patients after acute anticholinesterase self-poisoning with OP or carbamate insecticides.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3243
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 16 years or older with suspected OP or carbamate insecticide self-poisoning admitted to medical wards with the cholinergic toxidrome requiring atropine.
• Diagnosis will be made on the basis of the cholinergic toxidrome clinical features (eg. small/pinpoint pupils, bronchorrhoea, sweating) or on the history of atropine administration with beneficial effect. The insecticide involved will be identified where possible from the history, the bottle brought in by the patient or relative, the patient/relative identifying the pesticide on a chart showing all locally available pesticides, and/or relatives sending a photo of the bottle by eg. WhatsApp.
• Patients who ingest combination products containing OP or carbamate insecticides will also be included.
• Inhibited blood cholinesterase activity as shown by routine clinical bedside test

Exclusion Criteria:

• Children aged <16 years.
• Patients who do not require atropine and have not had it prior to presentation during this episode.
• Normal blood cholinesterase activity
• Self-reported known pregnancy (as per South Asian practice, no attempt will be made to formally test for pregnancy in the patients due to the issue of confidentiality in the acute care situation in these hospitals and the social consequences of an unexpected positive response)
• Known occupational and homicidal poisoning
• Past medical history of severely impaired renal function
• Hypersensitivity to magnesium and its salts
• Patients who have had a myocardial infarction or unstable angina in the last month
• Patients with traumatic subarachnoid haemorrhage
• Lack of informed consent (unaccompanied unconscious patients and others)

Related Conditions & MeSH terms

• Anticholinesterase Insecticide Poisoning
• Pesticide Poisoning
• Poisoning

Intervention

Drug:
• Magnesium Sulfate
Treatment in addition to standard therapy
• Nimodipine
Treatment in addition to standard therapy

Locations

Country	Name	City	State
Bangladesh	Shaheed Ziaur Rahman Medical College	Bogra	Silimpur
Bangladesh	Chattogram Medical College Hospital	Chittagong
Bangladesh	Jashore Medical College Hospital	Jessore
Bangladesh	Khulna Medical College Hospital	Khulna
Bangladesh	Rajshahi Medical College Hospital	Rajshahi	Rajshahi
Bangladesh	Rangpur Medical College Hospital	Rangpur
Bangladesh	Sylhet MAG Osmani Medical College Hospital	Sylhet

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Toxicology Society of Bangladesh

Country where clinical trial is conducted

Bangladesh, 

References & Publications (1)

Brvar M, Chan MY, Dawson AH, Ribchester RR, Eddleston M. Magnesium sulfate and calcium channel blocking drugs as antidotes for acute organophosphorus insecticide poisoning - a systematic review and meta-analysis. Clin Toxicol (Phila). 2018 Aug;56(8):725-736. doi: 10.1080/15563650.2018.1446532. Epub 2018 Mar 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Whether dead or alive at hospital discharge	through to hospital discharge, median 1 week