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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.
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Antibiotic Centre for Primary Care, University of Oslo
Oslo, Norway
Start Date
June 1, 2011
Primary Completion Date
December 1, 2013
Completion Date
December 1, 2014
Last Updated
December 12, 2014
225
ESTIMATED participants
Doxycycline
DRUG
Phenoxymethylpenicillin
DRUG
Amoxicillin
DRUG
Lead Sponsor
Morten Lindbaek
Collaborators
NCT07226882
NCT05641116
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06579235