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

September 28, 2023 updated by: University of Edinburgh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3243

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Bangladesh
      • Chittagong, Bangladesh, 4203
        • Recruiting
        • Chattogram Medical College Hospital
        • Contact:
          • Prof Aniruddha Ghose
        • Principal Investigator:
          • Prof Aniruddha Ghose
      • Jessore, Bangladesh
        • Recruiting
        • Jashore Medical College Hospital
        • Contact:
          • Dr Goutam Acherjya
        • Principal Investigator:
          • Dr Goutam Acherjya
      • Khulna, Bangladesh
        • Recruiting
        • Khulna Medical College Hospital
        • Contact:
          • Dr Pritish Tarafder
        • Principal Investigator:
          • DR PRITISH TARAFDER
      • Rangpur, Bangladesh
        • Recruiting
        • Rangpur Medical College Hospital
        • Contact:
          • Prof. Dr. Md. Mahfuzer Rahman
        • Principal Investigator:
          • Prof. Dr. Md. Mahfuzer Rahman
      • Sylhet, Bangladesh
        • Recruiting
        • Sylhet MAG Osmani Medical College Hospital
        • Contact:
          • Prof Shishir Ranjan Chakraborty
        • Principal Investigator:
          • Prof Shishir Ranjan Chakraborty
    • Rajshahi
      • Rājshāhi, Rajshahi, Bangladesh, 6100
        • Recruiting
        • Rajshahi Medical College Hospital
        • Contact:
          • Prof Khalilur Rahman
        • Principal Investigator:
          • Prof Khalilur Rahman
    • Silimpur
      • Bogra, Silimpur, Bangladesh, 5800
        • Recruiting
        • Shaheed Ziaur Rahman Medical College
        • Contact:
          • Prof Dr. Md. Halimur Rashid
        • Principal Investigator:
          • Prof Dr. Md. Halimur Rashid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard therapy
Active Comparator: Magnesium sulfate
Standard therapy plus magnesium sulfate
Drug: Magnesium Sulfate
Treatment in addition to standard therapy
Active Comparator: Nimodipine
Standard therapy plus nimodipine
Drug: Nimodipine
Treatment in addition to standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: through to hospital discharge, median 1 week
Whether dead or alive at hospital discharge
through to hospital discharge, median 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

Toxicology Society of Bangladesh

Investigators

  • Principal Investigator: Dr Fazle Rabbi Chowdhury, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

April 22, 2019

First Posted (Actual)

April 23, 2019

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC19003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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