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Trial record 1 of 1 for:    01368341 | "Borrelia Infections"
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Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice (NorTick_EM)

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ClinicalTrials.gov Identifier: NCT01368341
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : December 12, 2014
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

Tracking Information
First Submitted Date  ICMJE June 6, 2011
First Posted Date  ICMJE June 7, 2011
Last Update Posted Date December 12, 2014
Study Start Date  ICMJE June 2011
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
Duration of Erythema migrans (EM) [ Time Frame: 1-90 days ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01368341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2011)
  • Subjective Health Complaints (SHC) [ Time Frame: 1 year ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice
Official Title  ICMJE 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.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Erythema Migrans
  • Erythema Chronicum Migrans
  • Borreliosis
  • Lyme Disease
  • Early Lyme Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
Publications * Eliassen KE, Reiso H, Berild D, Lindbæk 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 6, 2011)
225
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01368341
Other Study ID Numbers  ICMJE EUDRACT 2010-023747
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Morten Lindbaek, University of Oslo
Study Sponsor  ICMJE Morten Lindbaek
Collaborators  ICMJE
  • Norwegian Institute of Public Health
  • Sorlandet Hospital HF
  • Norwegian University of Life Sciences
Investigators  ICMJE
Principal Investigator: Morten Lindbak, Professor University of Oslo
PRS Account University of Oslo
Verification Date December 2014

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