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New mass spec test could spot lyme disease faster

NCT ID NCT02414789

Diagnosis Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 14, 2026 · Updated 2 times

Summary

This study tested a new diagnostic method (mass spectrometry) to detect Lyme disease bacteria in skin biopsies from 84 people with early Lyme rash (erythema migrans). The new method was compared to standard PCR and culture tests. The goal was to see if the new technique could identify the bacteria more often than existing methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a faster, more accurate diagnostic test for early Lyme disease.
What could go wrong
This is a small, completed study testing a new method against existing ones. The new test may not prove more sensitive or practical for routine use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

84 people

The number who actually took part.

Started

Aug 2015

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Erythema migrant as criteria EUCALB or atypical form associated to tick's sting * Patient having signed a consent * Patient affiliated to a social security scheme Exclusion Criteria: * Prior treatment with antibiotics * Erythema migrans on the face * Bleeding disorders * Anticoagulant treatment * Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)

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Conditions

The condition(s) this trial relates to.

disease fissured tongue Glossitis, Benign Migratory Lyme disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erythema migrans

Contacts and locations

Locations

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, France

  • Centre Hospitalo-Universitaire Jean Minjoz

    Besançon, France

  • Hôpital Bel Air

    Thionville, France

  • Hôpital E. Muller

    Mulhouse, France

  • Hôpital Pasteur

    Colmar, France

  • Hôpital Robert Debré

    Reims, France

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

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