Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome

NCT01518192 | Completed Phase 4 Results

• 1 other identifier: EM-DC
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii.
• Controversy exists over the significance and even the existence of post-Lyme disease symptoms because of the high rate of similar background symptoms in the general population. Purpose: The two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are:
• To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and
• to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.

Conditions

Erythema Migrans; Post-Lyme Disease Symptoms

Keywords

erythema migrans; doxycycline; cefuroxime axetil; post-Lyme disease symptoms; background symptoms in general population

Outcome Measures

Primary Outcomes (5)

• Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days

  Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion

  at 14 days post inclusion

• Adverse Events

  Number of patients reporting adverse events

  at 14 days

• Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months

  Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 2 months post inclusion

  2 months

• Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 6months

  Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 6 months post inclusion

  6 months

• Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 12 Months

  Number of patients with objective Lyme disease manifestations and/or post-Lyme disease symptoms in patients treated for solitary erythema migrans at 12 months post inclusion

  12 months

Secondary Outcomes (3)

• New or Increased Symptoms Since Erythema Migrans in Patients and Controls at 6 Months.

  6 months

• New or Increased Symptoms Since Erythema Migrans in Patients Controls at 12 Months.

  12 months

• Selected Subjective Symptoms in Patients and Control Subjects

  Examination at 12 months

Study Arms (2)

1Doxycycline

ACTIVE COMPARATOR

Drug: doxycycline

2 Cefuroxime axetil

ACTIVE COMPARATOR

Drug: cefuroxime axetil

Interventions

doxycycline DRUG

100 mg bid; 15 days

1Doxycycline

cefuroxime axetil DRUG

500 mg bid; 15 days

2 Cefuroxime axetil

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients 15 or more years old
• with typical erythema migrans
• evaluated between 6/06 and 9/06
• evaluated at the Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency: collaborator

Study Sites (2)

Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana

Ljubljana, 1000, Slovenia

Location

Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

Ljubljana, 1525, Slovenia

Location

MeSH Terms

Conditions

Glossitis, Benign Migratory

Interventions

Doxycycline; cefuroxime axetil

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Limitations and Caveats

Medical explanation besides Lyme disease of the symptoms in patients was based on history and physical examination, therefore some other medical explanations might have been missed. With regard to controls this was even more likely.

Results Point of Contact

• Title: Franc Strle
• Organization: Department of Infectious Diseases, University Medical Center Ljubljana

franc.strle@kclj.si

+386 1 522 2610

Study Officials

• Daša Cerar, MD

  Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

  PRINCIPAL INVESTIGATOR

• Franc Strle, MD

  Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: January 25, 2012
• Study Start: June 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2009
• Last Updated: January 25, 2012
• Results First Posted: January 25, 2012

Record last verified: 2011-12

Locations

SL (2)