CClinicalTrials.gg
CompletedNCT01475708Updated Mar 24, 2016

Doxycycline in Therapy of Erythema Migrans

An observational study in Lyme Borreliosis, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-24.

Sponsored by University Medical Centre Ljubljana · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
400
Ages
15 Years and older
Sex
All
01

Study summary

The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.

Read the detailed description

Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

02

Conditions studied

  • Lyme Borreliosis

Keywords

  • Lyme borreliosis
  • Erythema migrans
  • Doxycycline
  • Subjective symptoms
  • Outcome
03

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.

Inclusion criteria

  • presence of erythema migrans
  • >15 years old
  • informed consent

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • lactation
  • multiple erythema migrans
  • already treated with antibiotic for this episode of Lyme borreliosis
  • allergy to doxycycline
  • treatment with drugs with known interactions with doxycycline
  • cerebrospinal fluid pleocytosis
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
400 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • no symptoms

    patients with erythema migrans and no additional newly onset symptoms treated with doxycycline

    Drug: Doxycycline

  • mild symptoms

    patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline

    Drug: Doxycycline

  • severe symptoms-lumbar puncture

    patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline

    Drug: Doxycycline

Interventions

  • DrugDoxycycline

    100 mg PO bid, 14 days

    Also known as: Doxy

05

What researchers measure

Primary outcomes

  1. Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.

    Time frame: 1 year follow-up

Secondary outcomes

  1. Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.

    Time frame: 1 year follow-up

06

Study locations

1 site
  • UMC Ljubljana, Department of Infectious Diseases
    Ljubljana, 1000, Slovenia
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT01475708
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Franc Strle (M.D., PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
Nov 21, 2011
Start date
May 2011
Primary completion
Oct 2014
Completion
Nov 2014
Last update
Mar 24, 2016

Study contacts

Franc Strle, MD PhD
study chair · UMC Ljubljana

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion