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
2 other identifiers
observational
6,120
2 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2025
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedStudy Start
First participant enrolled
June 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
March 30, 2026
March 1, 2026
2.5 years
November 20, 2024
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary objective 1
To determine the sensitivity and specificity of the POC formate assay compared to the laboratory formate assay.
Day1
Primary objective 2
Evaluate the use of the POC formate assay for methanol poisoning. Compare clinical and resource use of using the POC formate assay by introducing the assay into routine clinical use.
Day1
Secondary Outcomes (1)
Secondary objective
Day1
Eligibility Criteria
The study population will include patients presenting to large referral hospitals in 2 countries (Bangladesh, India) with suspicion of methanol poisoning or unexplained metabolic acidosis.
You may qualify if:
- Patients presenting with suspected methanol poisoning or metabolic acidosis of unknown cause, including:
- Children aged 16-17 years, who are willing to provide assent.
- Parents/Guardians of children who are able and willing to provide consent.
- Adults (aged 18 years with no upper age limit) who are willing to provide informed consent.
- Participants who lack capacity to consent for themselves but who have a relative who is willing and able to provide informed consent on behalf of the participant.
- Suspected methanol poisoning will be based on clinician judgement using the following typical indicators of possible methanol ingestion:
- History of:
- Intake of illegal/bootleg/spurious alcohol, and/or
- Other patients admitted with confirmed/suspected methanol poisoning and/or
- Time from intake to symptoms \>6-12 h
- Symptoms/clinical findings
- Coma, and/or
- Hyperventilation (respiratory rate \[RR\] \>20/min) and/or dyspnea, and/or
- Visual disturbances (blurred vision, blindness), and/or
- Gastrointestinal symptoms (vomiting, abdominal pain), and/or
- +6 more criteria
You may not qualify if:
- Children aged 16-17 years, who are unwilling to provide assent.
- Parents/Guardians of children who are unable or unwilling to provide consent.
- Adults (aged 18 years with no upper age limit) who are unwilling to provide informed consent.
- Participants who lack capacity to consent for themselves and who do not have a relative who is willing and able to provide informed consent on behalf of the participant (i.e. unaccompanied unconscious patients and others)
- Individuals previously recruited to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
SZMCH
Bogra, Bogura, 5800, Bangladesh
Rahshahi medical college hospital
Rajshahi, Rajshahi Division, 6000, Bangladesh
Chittagong Medical College Hospital
Chittagong, Bangladesh
Dhaka Medical College Hospital
Dhaka, 1205, Bangladesh
Mag Osmania Medical College Hospital Sylhet
Sylhet, Bangladesh
PGIEMR
Chandigarh, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Prof Michael Eddleston
University of Edinburgh
Central Study Contacts
Michael Eddleston
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2024
First Posted
March 18, 2025
Study Start
June 22, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
February 28, 2028
Last Updated
March 30, 2026
Record last verified: 2026-03