The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers

The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.

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Key information

Conditions

Organophosphate Poisoning Chemically-Induced Disorders Poisoning

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

male
minimum age 18 years
hand pressured backpack sprayer usage
used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification

Exclusion criteria

usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
unwilling to stay pesticide-free seven days prior to each of the two spray sessions
medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)

Treatment and study plan

Organophosphate

Other

Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous

Placebo

Other

Multineem, WHO Class U: Unlikely to present acute hazard in normal use

Other names: Biopesticide

Primary outcomes

Change in self-reported acute organophosphate poisoning symptoms from baseline to follow up

Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session

Obtained using a structured questionnaire interview. The definition of symptoms was based on WHO's standardized list of clinical presentations of acute organophosphate poisoning.
Change in Plasma Cholinesterase (PchE) activity from baseline to follow up

Time frame: Obtained just before (baseline) and 30 minutes after (baseline) each spray session

PchE activity was measured with a blood test using a Test-mate Che Cholinesterase System (Model 400) with a PchE Plasma Cholinesterase Assay Kit (Model 470).

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

Augustinus Fonden

Registry information

Official study title

The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Jul 20, 2016
Registry last updated: Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed