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