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Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning (CCBOC)

Primary Purpose

Anticholinesterase Insecticide Poisoning, Pesticide Poisoning

Status
Recruiting
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
Magnesium Sulfate
Nimodipine
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anticholinesterase Insecticide Poisoning

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rajshahi Medical College HospitalRecruiting
  • Shaheed Ziaur Rahman Medical CollegeRecruiting
  • Chattogram Medical College HospitalRecruiting
  • Jashore Medical College HospitalRecruiting
  • Khulna Medical College HospitalRecruiting
  • Rangpur Medical College HospitalRecruiting
  • Sylhet MAG Osmani Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

Control

Magnesium sulfate

Nimodipine

Arm Description

Standard therapy

Standard therapy plus magnesium sulfate

Standard therapy plus nimodipine

Outcomes

Primary Outcome Measures

Mortality
Whether dead or alive at hospital discharge

Secondary Outcome Measures

Full Information

First Posted
April 17, 2019
Last Updated
September 28, 2023
Sponsor
University of Edinburgh
Collaborators
Toxicology Society of Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT03925025
Brief Title
Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 11, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh
Collaborators
Toxicology Society of Bangladesh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticholinesterase Insecticide Poisoning, Pesticide Poisoning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3243 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard therapy
Arm Title
Magnesium sulfate
Arm Type
Active Comparator
Arm Description
Standard therapy plus magnesium sulfate
Arm Title
Nimodipine
Arm Type
Active Comparator
Arm Description
Standard therapy plus nimodipine
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Treatment in addition to standard therapy
Intervention Type
Drug
Intervention Name(s)
Nimodipine
Intervention Description
Treatment in addition to standard therapy
Primary Outcome Measure Information:
Title
Mortality
Description
Whether dead or alive at hospital discharge
Time Frame
through to hospital discharge, median 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Eddleston, ScD
Phone
01312426776
Email
m.eddleston@ed.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Fazle Rabbi Chowdhury, MD
Email
mastershakil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Fazle Rabbi Chowdhury, MD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajshahi Medical College Hospital
City
Rājshāhi
State/Province
Rajshahi
ZIP/Postal Code
6100
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Khalilur Rahman
First Name & Middle Initial & Last Name & Degree
Prof Khalilur Rahman
Facility Name
Shaheed Ziaur Rahman Medical College
City
Bogra
State/Province
Silimpur
ZIP/Postal Code
5800
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Dr. Md. Halimur Rashid
First Name & Middle Initial & Last Name & Degree
Prof Dr. Md. Halimur Rashid
Facility Name
Chattogram Medical College Hospital
City
Chittagong
ZIP/Postal Code
4203
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Aniruddha Ghose
First Name & Middle Initial & Last Name & Degree
Prof Aniruddha Ghose
Facility Name
Jashore Medical College Hospital
City
Jessore
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Goutam Acherjya
First Name & Middle Initial & Last Name & Degree
Dr Goutam Acherjya
Facility Name
Khulna Medical College Hospital
City
Khulna
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Pritish Tarafder
First Name & Middle Initial & Last Name & Degree
DR PRITISH TARAFDER
Facility Name
Rangpur Medical College Hospital
City
Rangpur
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Md. Mahfuzer Rahman
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Md. Mahfuzer Rahman
Facility Name
Sylhet MAG Osmani Medical College Hospital
City
Sylhet
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof Shishir Ranjan Chakraborty
First Name & Middle Initial & Last Name & Degree
Prof Shishir Ranjan Chakraborty

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
Six months after primary data analysis is published
IPD Sharing Access Criteria
From academic group with clear analysis plan
Citations:
PubMed Identifier
29557685
Citation
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.
Results Reference
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Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

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