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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian Institute of Public Health
Sorlandet Hospital HF
Norwegian University of Life Sciences
Information provided by (Responsible Party):
Morten Lindbaek, University of Oslo
ClinicalTrials.gov Identifier:
NCT01368341
First received: June 6, 2011
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Erythema Migrans
Erythema Chronicum Migrans
Borreliosis
Lyme Disease
Early Lyme Disease
Drug: Doxycycline
Drug: Phenoxymethylpenicillin
Drug: Amoxicillin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by University of Oslo:

Primary Outcome Measures:
  • Duration of Erythema migrans (EM) [ Time Frame: 1-90 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Subjective Health Complaints (SHC) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    By questionnaire on day 1, day 90 and day 360 the patients are asked about their SHC which is a standardized set of parametres. The 3 treatment groups are compaired to each other and to 1200 healthy blood donors receiving the same questionnaire. There are 29 standardized and 3 Lyme disease related subjects to be measured.

  • Borrelia antibodies [ Time Frame: 1-90 days ] [ Designated as safety issue: No ]
    Normally antibody production is not measured for EM as it is a clinical diagnosis, and less than 50 percent of EM-patients are expected to develop antibodies in the first period. However antibodies are here measured on day 1, day 14 and day 90 to see whether there are differences between the groups. Also the results will be compared to the blood donors.

  • Side symptoms [ Time Frame: 1-14 days ] [ Designated as safety issue: Yes ]

    The EM in it self is often asymptomatic, and fever, headache and nerval palsy can be a sign of disseminated disease or co-infection. On the quiestionnaire to the pasient and doctor on day 1, in the patient diary day 1-14 and on the questionnaire to the doctor on day 14 these side symptoms are registered.

    In a potential case, where it turns out that the patient suffers from disseminated disease this will be regostered as treatment failure in the study and the patient treated and/or referred as normal.


  • Side effects [ Time Frame: 1-14 days ] [ Designated as safety issue: No ]
    The antibiotic tretments are expected to be non-inferior to each other. Potensial side effects as nausea, diarrhea etc. are registered in the patients diary day 1-14 and in the doctors quiestionnaire on day 14.

  • Subgrouping and TBE [ Time Frame: 1-14 days ] [ Designated as safety issue: No ]
    For volunteers there is an additional PCR-analysis on punch biopsy from the EM for subgroupring of the Borrelia bacteria. TBE-antibodies are measured on day 14.


Estimated Enrollment: 225
Study Start Date: June 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Doxycycline
Doxycycline, 100 mg, tablets, b.i.d., 14 days
Drug: Doxycycline
1 tablet, 100 mg, b.i.d. 14 days
Other Name: Doksycycline 100 mg HEXAL, no. 30
Active Comparator: Penicillin
Phenoxymethylpenicillin tablets 650 mg. 2 tablets t.i.d. 14 days
Drug: Phenoxymethylpenicillin
Tablet 650 mg, 2 tablets, t.i.d., 14 days
Other Name: Weifapenin 650 mg, WEIFA, no. 100
Active Comparator: Amoxicillin
Amoxicillin 500 mg capsula, t.i.d., 14 days
Drug: Amoxicillin
Capsula, 500 mg, t.i.d., 14 days
Other Name: Amoxicillin 500 mg MYLAN, no. 30 + 20.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01368341

Locations
Norway
Antibiotic Centre for Primary Care, University of Oslo
Oslo, Norway, 0318
Sponsors and Collaborators
Morten Lindbaek
Norwegian Institute of Public Health
Sorlandet Hospital HF
Norwegian University of Life Sciences
Investigators
Principal Investigator: Morten Lindbak, Professor University of Oslo
  More Information

Additional Information:
No publications provided

Responsible Party: Morten Lindbaek, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT01368341     History of Changes
Other Study ID Numbers: EUDRACT 2010-023747
Study First Received: June 6, 2011
Last Updated: February 13, 2014
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Oslo:
Antibiotics
General Practice
Erythema migrans
Borrelia
Ticks

Additional relevant MeSH terms:
Lyme Disease
Borrelia Infections
Erythema
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Doxycycline
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on October 19, 2014