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Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

Information source: University of Oslo
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erythema Migrans; Erythema Chronicum Migrans; Borreliosis; Lyme Disease; Early Lyme Disease

Intervention: Doxycycline (Drug); Phenoxymethylpenicillin (Drug); Amoxicillin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Morten Lindbaek

Official(s) and/or principal investigator(s):
Morten Lindbak, Professor, Principal Investigator, Affiliation: University of Oslo


Tick borne diseases are increasing in Norway. Lyme borreliosis is the most common infection. Erythema migrans is mainly diagnosed and treated in general practice. There is disagreement about what antibiotic treatment that should be given. An RCT with the three most common antibiotics used, will support data for revision of national guidelines.

Clinical Details

Official title: Tick Borne Diseases in Norwegian General Practice. A Randomized, Controlled Trial for Treatment of Erythema Migrans in Norwegian General Practice. A Comparison of Phenoxymethylpenicillin, Amoxicillin and Doxycycline.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Duration of Erythema migrans (EM)

Secondary outcome:

Subjective Health Complaints (SHC)

Borrelia antibodies

Side symptoms

Side effects

Subgrouping and TBE

Detailed description: Comparison of phenoxymethylpenicillin, doxycycline and amoxicillin for Erythema migrans in Norwegian general practice. Every patient receives 14 days of antibiotic treatment. There are blood samples for measurement of Borrelia antibody level at day 1, 14 and 90 and questionnaires on subjective health complaints (SHC) at day 1, 90 and 360. Side symptoms and side effects are registered. For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgrouping of the Borrelia bacteria. TBE-antibodies are measured on day 14. Antibody levels and SHC-scores are compared to healthy blood donors.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Clinical diagnosis of Erythema migrans

- Over the age of 18

- Signing an concent form after information in writing

Exclusion Criteria:

- Allergic to any of the three drugs in the study

- Under the age of 18

- Pregnancy

- Dementia or known drug abuse

- Antibiotic treatment last 14 days

- Concommitant Chemotherapy or immunomodulating therapy

- Concommitant use of medicine with potential interaction (defined in protocol)

Locations and Contacts

Antibiotic Centre for Primary Care, University of Oslo, Oslo 0318, Norway
Additional Information

Information for the study general practitioners

Information from the Antibiotic Centre for Primary Care

Starting date: June 2011
Last updated: December 11, 2014

Page last updated: August 23, 2015

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