RecruitingNCT06881641

A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning

Sensitivity, Specificity, and Acceptability of a Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning: Prospective Observational and Randomized Studies


Sponsor

University of Edinburgh

Enrollment

6,120 participants

Start Date

Jun 22, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Methanol poisoning is a serious issue, particularly in low- and middle-income countries (LMICs), where outbreaks can devastate communities. Diagnosing methanol poisoning is challenging because its symptoms mimic many other conditions, and traditional diagnostic methods require expensive lab equipment. Unfortunately, this often means doctors do not even consider methanol poisoning as a diagnosis. Methanol itself isn't highly toxic, but when the body breaks it down into formate, it becomes dangerous, leading to brain swelling and even death. To address this, a study team has developed a new method to diagnose methanol poisoning using a single drop of blood with a device that can be used at the bedside, eliminating the need for any lab equipment. This point-of-care (POC) test measures formate, which is only present in cases of methanol poisoning. The project consists of two sequential studies. The first study aims to compare the effectiveness of the POC formate test against standard lab tests, which can take several hours. The findings from this study will inform the second study. The second study is a feasibility cluster randomized controlled trial. In this trial, entire hospitals, rather than individual patients, are randomly assigned different approaches, similar to tossing a coin. The goal is to determine whether this trial design can be used in larger-scale research to evaluate clinical outcomes. Specifically, it will examine whether the POC formate test can accelerate accurate diagnosis, enabling prompt treatment and preventing deaths.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with metabolic acidosis. The study is currently recruiting participants at 6 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

SZMCH

Bogra, Bogura, Bangladesh

Rahshahi medical college hospital

Rajshahi, Rajshahi Division, Bangladesh

Chittagong Medical College Hospital

Chittagong, Bangladesh

Dhaka Medical College Hospital

Dhaka, Bangladesh

Mag Osmania Medical College Hospital Sylhet

Sylhet, Bangladesh

PGIEMR

Chandigarh, India

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NCT06881641


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