Clinical trial NCT01368341: Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erythema Migrans
Erythema Chronicum Migrans
Borreliosis
Lyme Disease
Early Lyme Disease
Keywords: Antibiotics
General Practice
Erythema migrans
Borrelia
Ticks
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Institute of Public Health
name: Sorlandet Hospital HF
name: Norwegian University of Life Sciences
First posted: 2011-06-07
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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)

Primary outcomes:
measure: Duration of Erythema migrans (EM)
timeFrame: 1-90 days
Secondary outcomes:
measure: Subjective Health Complaints (SHC)
timeFrame: 1 year
measure: Borrelia antibodies
timeFrame: 1-90 days
measure: Side symptoms
timeFrame: 1-14 days
measure: Side effects
timeFrame: 1-14 days
measure: Subgrouping and TBE
timeFrame: 1-14 days
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Antibiotic Centre for Primary Care, University of Oslo
Study officials:
affiliation: University of Oslo
name: Morten Lindbak, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eliassen KE, Reiso H, Berild D, Lindbaek M. Comparison of phenoxymethylpenicillin, amoxicillin, and doxycycline for erythema migrans in general practice. A randomized controlled trial with a 1-year follow-up. Clin Microbiol Infect. 2018 Dec;24(12):1290-1296. doi: 10.1016/j.cmi.2018.02.028. Epub 2018 Mar 2.