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Effectiveness of Calcium Channel Blockade for OP and Carbamate Pesticide Poisoning

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03925025
Acronym
CCBOC
Enrollment
1728
Registered
2019-04-23
Start date
2020-06-11
Completion date
2025-04-30
Last updated
2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticholinesterase Insecticide Poisoning, Pesticide Poisoning

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.

Interventions

DRUGMagnesium Sulfate

Treatment in addition to standard therapy

DRUGNimodipine

Treatment in addition to standard therapy

Sponsors

Toxicology Society of Bangladesh
CollaboratorOTHER
University of Edinburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Mortalitythrough to hospital discharge, median 1 weekWhether dead or alive at hospital discharge

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026