NCT01368341

Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: Morten Lindbaek · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erythema Migrans
• Erythema Chronicum Migrans
• Borreliosis
• Lyme Disease
• Early Lyme Disease

Interventions

Type	Name	Description
DRUG	Doxycycline	1 tablet, 100 mg, b.i.d. 14 days
DRUG	Phenoxymethylpenicillin	Tablet 650 mg, 2 tablets, t.i.d., 14 days
DRUG	Amoxicillin	Capsula, 500 mg, t.i.d., 14 days

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2011-06-07
• Last updated: 2014-12-12

Locations

1 site across 1 country: Norway