Actively Recruiting

Age: 16Years +
All Genders
NCT06881641

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

Led by University of Edinburgh · Updated on 2026-03-30

6120

Participants Needed

6

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients presenting with suspected methanol poisoning or metabolic acidosis of unknown cause
  • Children aged 16-17 years willing to provide assent
  • Parents or guardians able and willing to provide consent for children
  • Adults aged 18 years or older willing to provide informed consent
  • Participants unable to consent but with a relative able and willing to provide consent on their behalf
Not Eligible

You will not qualify if you...

  • Children aged 16-17 years unwilling to provide assent
  • Parents or guardians unable or unwilling to provide consent for children
  • Adults unwilling to provide informed consent
  • Participants unable to consent with no relative able to provide consent
  • Individuals previously recruited to the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

SZMCH

Bogra, Bogura, Bangladesh, 5800

Actively Recruiting

2

Rahshahi medical college hospital

Rajshahi, Rajshahi Division, Bangladesh, 6000

Actively Recruiting

3

Chittagong Medical College Hospital

Chittagong, Bangladesh

Actively Recruiting

4

Dhaka Medical College Hospital

Dhaka, Bangladesh, 1205

Actively Recruiting

5

Mag Osmania Medical College Hospital Sylhet

Sylhet, Bangladesh

Actively Recruiting

6

PGIEMR

Chandigarh, India

Not Yet Recruiting

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Research Team

P

Prof Michael Eddleston, BA PhDScD FRCPEdin FEAPCCT

CONTACT

M

Michael Eddleston

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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