Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

NCT01368341 | Completed Phase 4 DMC

• 1 other identifier: EUDRACT 2010-023747
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Antibiotics; General Practice; Erythema migrans; Borrelia; Ticks

Outcome Measures

Primary Outcomes (1)

• Duration of Erythema migrans (EM)

  On day 1 duration until first the consulation is registered. Day 1-14 the EM is registered in a patient diary. On day 14 the doctor is asked whether the EM has disseapeared. If not the patient is followed by phone from the researchers. On day 90 they are additionally asked for how long it lasted.

  1-90 days

Secondary Outcomes (5)

• Subjective Health Complaints (SHC)

  1 year

• Borrelia antibodies

  1-90 days

• Side symptoms

  1-14 days

• Side effects

  1-14 days

• Subgrouping and TBE

  1-14 days

Study Arms (3)

Doxycycline

ACTIVE COMPARATOR

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

Drug: Doxycycline

Penicillin

ACTIVE COMPARATOR

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

Drug: Phenoxymethylpenicillin

Amoxicillin

ACTIVE COMPARATOR

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

Drug: Amoxicillin

Interventions

Doxycycline DRUG

1 tablet, 100 mg, b.i.d. 14 days

Also known as: Doksycycline 100 mg HEXAL, no. 30

Doxycycline

Phenoxymethylpenicillin DRUG

Tablet 650 mg, 2 tablets, t.i.d., 14 days

Also known as: Weifapenin 650 mg, WEIFA, no. 100

Penicillin

Amoxicillin DRUG

Capsula, 500 mg, t.i.d., 14 days

Also known as: Amoxicillin 500 mg MYLAN, no. 30 + 20.

Amoxicillin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Erythema migrans
• Over the age of 18
• Signing an concent form after information in writing

You may not qualify if:

• 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)

Sponsors & Collaborators

• Morten Lindbaek: lead
• Norwegian Institute of Public Health: collaborator
• Sorlandet Hospital HF: collaborator
• Norwegian University of Life Sciences: collaborator

Study Sites (1)

Antibiotic Centre for Primary Care, University of Oslo

Oslo, 0318, Norway

Location

Related Publications (1)

• 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.

  PMID: 29505880 DERIVED

Related Links

• Information from the Antibiotic Centre for Primary Care

MeSH Terms

Conditions

Glossitis, Benign Migratory; Erythema Chronicum Migrans; Borrelia Infections; Lyme Disease

Interventions

Doxycycline; Penicillin V; Amoxicillin

Condition Hierarchy (Ancestors)

Glossitis; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Spirochaetales Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Tick-Borne Diseases; Vector Borne Diseases; Erythema; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G

Study Officials

• Morten Lindbak, Professor

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

NO (1)