NCT00910715

Brief Summary

The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

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

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 18, 2012

Completed
Last Updated

June 2, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

May 28, 2009

Results QC Date

October 5, 2011

Last Update Submit

May 4, 2017

Conditions

Erythema Chronicum Migrans

Keywords

erythema migransLyme borreliosisdoxycycline treatmentoutcomesubjective symptoms

Outcome Measures

Primary Outcomes (1)

  • Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.

    At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.

    1 year follow-up

Secondary Outcomes (1)

  • Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.

    6 months after treatment

Study Arms (3)

EM-10 days doxycycline

ACTIVE COMPARATOR
Drug: doxycycline

EM-doxycycline 15 days

ACTIVE COMPARATOR
Drug: doxycycline

controls

PLACEBO COMPARATOR
Drug: placebo

Interventions

doxycyclineDRUG

doxycycline 100 mg bid, 10 days

EM-10 days doxycycline
placeboDRUG

control subjects without a history of Lyme borreliosis

controls

Eligibility Criteria

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

You may qualify if:

  • solitary erythema migrans in patients \> 15 years

You may not qualify if:

  • a history of Lyme borreliosis in the past
  • pregnancy or lactation
  • immunocompromised status
  • serious adverse event to doxycycline
  • taking antibiotic with antiborrelial activity within 10 days
  • multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

Location

Related Publications (2)

  • Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.

    PMID: 30075748DERIVED

  • Stupica D, Lusa L, Ruzic-Sabljic E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. doi: 10.1093/cid/cis402. Epub 2012 Apr 20.

    PMID: 22523260DERIVED

MeSH Terms

Conditions

Erythema Chronicum MigransGlossitis, Benign MigratoryLyme Disease

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousTick-Borne DiseasesVector Borne DiseasesErythemaSkin DiseasesSkin and Connective Tissue DiseasesGlossitisTongue DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Dr.Dasa Stupica
Organization
UMC Ljubljana, Department of Infectious Diseases
cerar.dasa@gmail.com
+386 1 522 2110

Study Officials

  • Franc Strle, MD

    UMC Ljubljana

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., PhD

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

June 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

June 2, 2017

Results First Posted

July 18, 2012

Record last verified: 2017-05

Locations

SL(1)