About this trial
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 criteria
Qualifiers
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.
Disqualifiers
• 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)
Trial design
Treatments tested in this trial
- Not listed