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

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.

NCT Number	NCT06881641
Lead Sponsor	University of Edinburgh
Conditions	Metabolic Acidosis
Enrollment	6,120 participants
Start Date	2025-06-22
Primary Completion	2027-12-31 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-03-30