Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice (NorTick_EM)

Morten Lindbaek

Status and phase: Completed; Phase 4

Conditions: Borreliosis; Erythema Chronicum Migrans; Erythema Migrans; Early Lyme Disease; Lyme Disease

Treatments: Drug: Amoxicillin; Drug: Doxycycline; Drug: Phenoxymethylpenicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT01368341

EUDRACT 2010-023747

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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225 participants in 3 patient groups

Doxycycline

Active Comparator group

Description:

Doxycycline, 100 mg, tablets, b.i.d., 14 days

Treatment:

Drug: Doxycycline

Penicillin

Active Comparator group

Description:

Phenoxymethylpenicillin tablets 650 mg. 2 tablets t.i.d. 14 days

Treatment:

Drug: Phenoxymethylpenicillin

Amoxicillin

Active Comparator group

Description:

Amoxicillin 500 mg capsula, t.i.d., 14 days

Treatment:

Drug: Amoxicillin