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

June 6, 2011
February 13, 2014
June 2011
December 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01368341 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Erythema Migrans
  • Erythema Chronicum Migrans
  • Borreliosis
  • Lyme Disease
  • Early Lyme Disease
  • Drug: Doxycycline
    1 tablet, 100 mg, b.i.d. 14 days
    Other Name: Doksycycline 100 mg HEXAL, no. 30
  • Drug: Phenoxymethylpenicillin
    Tablet 650 mg, 2 tablets, t.i.d., 14 days
    Other Name: Weifapenin 650 mg, WEIFA, no. 100
  • Drug: Amoxicillin
    Capsula, 500 mg, t.i.d., 14 days
    Other Name: Amoxicillin 500 mg MYLAN, no. 30 + 20.
  • Active Comparator: Doxycycline
    Doxycycline, 100 mg, tablets, b.i.d., 14 days
    Intervention: Drug: Doxycycline
  • Active Comparator: Penicillin
    Phenoxymethylpenicillin tablets 650 mg. 2 tablets t.i.d. 14 days
    Intervention: Drug: Phenoxymethylpenicillin
  • Active Comparator: Amoxicillin
    Amoxicillin 500 mg capsula, t.i.d., 14 days
    Intervention: Drug: Amoxicillin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
225
December 2014
December 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01368341
EUDRACT 2010-023747
Yes
Morten Lindbaek, University of Oslo
Morten Lindbaek
  • Norwegian Institute of Public Health
  • Sorlandet Hospital HF
  • Norwegian University of Life Sciences
Principal Investigator: Morten Lindbak, Professor University of Oslo
University of Oslo
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP