Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice (NorTick_EM)
Erythema Chronicum Migrans
Early Lyme Disease
|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.|
- 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.
- 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.
|Study Start Date:||June 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Doxycycline
Doxycycline, 100 mg, tablets, b.i.d., 14 days
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
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
Capsula, 500 mg, t.i.d., 14 days
Other Name: Amoxicillin 500 mg MYLAN, no. 30 + 20.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368341
|Antibiotic Centre for Primary Care, University of Oslo|
|Oslo, Norway, 0318|
|Principal Investigator:||Morten Lindbak, Professor||University of Oslo|