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Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice

NCT ID: NCT01368341

Last Updated: 2014-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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

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Erythema Migrans Erythema Chronicum Migrans Borreliosis Lyme Disease Early Lyme Disease

Keywords

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Antibiotics General Practice Erythema migrans Borrelia Ticks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Doxycycline

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

Group Type ACTIVE_COMPARATOR

Doxycycline

Intervention Type DRUG

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

Penicillin

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

Group Type ACTIVE_COMPARATOR

Phenoxymethylpenicillin

Intervention Type DRUG

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

Amoxicillin

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

Group Type ACTIVE_COMPARATOR

Amoxicillin

Intervention Type DRUG

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

Interventions

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Doxycycline

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

Intervention Type DRUG

Phenoxymethylpenicillin

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

Intervention Type DRUG

Amoxicillin

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

Intervention Type DRUG

Other Intervention Names

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Doksycycline 100 mg HEXAL, no. 30 Weifapenin 650 mg, WEIFA, no. 100 Amoxicillin 500 mg MYLAN, no. 30 + 20.

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Institute of Public Health

OTHER_GOV

Sponsor Role collaborator

Sorlandet Hospital HF

OTHER_GOV

Sponsor Role collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role collaborator

Morten Lindbaek

OTHER

Sponsor Role lead

Responsible Party

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Morten Lindbaek

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Morten Lindbak, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Antibiotic Centre for Primary Care, University of Oslo

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 29505880 (View on PubMed)

Related Links

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http://www.antibiotikasenteret.no

Information from the Antibiotic Centre for Primary Care

Other Identifiers

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EUDRACT 2010-023747

Identifier Type: -

Identifier Source: org_study_id