NCT01475708

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

3.4 years

First QC Date

November 16, 2011

Last Update Submit

March 23, 2016

Conditions

Lyme Borreliosis

Keywords

Lyme borreliosisErythema migransDoxycyclineSubjective symptomsOutcome

Outcome Measures

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.

    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.

    1 year follow-up

Study Arms (3)

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

DoxycyclineDRUG

100 mg PO bid, 14 days

Also known as: Doxy
mild symptomsno symptomssevere symptoms-lumbar puncture

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood, serum, cerebrospinal fluid, skin tissue

MeSH Terms

Conditions

Lyme DiseaseGlossitis, Benign Migratory

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne DiseasesGlossitisTongue DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Franc Strle, MD PhD

    UMC Ljubljana

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 21, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2014

Study Completion

November 1, 2014

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

SL(1)