NCT03584919

Brief Summary

A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
509

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2006

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

June 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2007

Completed
10.7 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

June 19, 2018

Last Update Submit

July 11, 2018

Conditions

Erythema Chronicum Migrans

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days

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

    One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)

Secondary Outcomes (1)

  • Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.

    12 months after treatment

Study Arms (3)

EM doxycycline

ACTIVE COMPARATOR

patients with EM who received doxycycline

Drug: doxycycline

EM cefuroxime axetil

ACTIVE COMPARATOR

patients with EM who received cefuroxime axetil

Drug: Cefuroxime Axetil 500Mg Tab

controls

PLACEBO COMPARATOR

control subjects without history of Lyme disease

Other: control subjects

Interventions

doxycyclineDRUG

patients received oral doxycycline 100 milgrams bid for 15 days

EM doxycycline
Cefuroxime Axetil 500Mg TabDRUG

patients received cefuroxime axetil 500 milgrams bid for 15 days

EM cefuroxime axetil
control subjectsOTHER

no intervention

controls

Eligibility Criteria

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

You may qualify if:

  • typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion \<5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

You may not qualify if:

  • Lyme disease previously
  • pregnancy or lactation
  • immunocompromised
  • serious adverse reaction to a beta-lactam or tetracycline drug in the past
  • received an antibiotic with known anti-borrelial activity within 10 days
  • multiple erythema migrans lesions
  • presence of an extracutaneous manifestation of Lyme disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

MeSH Terms

Conditions

Erythema Chronicum Migrans

Interventions

Doxycyclinecefuroxime axetil

Condition Hierarchy (Ancestors)

Lyme DiseaseGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousTick-Borne DiseasesVector Borne DiseasesErythemaSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 12, 2018

Study Start

June 1, 2006

Primary Completion

September 30, 2007

Study Completion

September 30, 2007

Last Updated

July 12, 2018

Record last verified: 2018-06