A Phase 4 interventional study of Doxycycline and Phenoxymethylpenicillin in Erythema Migrans, Erythema Chronicum Migrans and Borreliosis, sponsored by Morten Lindbaek. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Morten Lindbaek · Phase 4, Interventional, and Treatment
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.
25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.
This study's planned enrollment of 225 is above the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.
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Doxycycline, 100 mg, tablets, b.i.d., 14 days
Drug: Doxycycline
Phenoxymethylpenicillin tablets 650 mg. 2 tablets t.i.d. 14 days
Drug: Phenoxymethylpenicillin
Amoxicillin 500 mg capsula, t.i.d., 14 days
Drug: Amoxicillin
1 tablet, 100 mg, b.i.d. 14 days
Also known as: Doksycycline 100 mg HEXAL, no. 30
Tablet 650 mg, 2 tablets, t.i.d., 14 days
Also known as: Weifapenin 650 mg, WEIFA, no. 100
Capsula, 500 mg, t.i.d., 14 days
Also known as: Amoxicillin 500 mg MYLAN, no. 30 + 20.
Duration of Erythema migrans (EM)
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.
Time frame: 1-90 days
Subjective Health Complaints (SHC)
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.
Time frame: 1 year
Borrelia antibodies
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.
Time frame: 1-90 days
Side symptoms
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.
Time frame: 1-14 days
Side effects
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.
Time frame: 1-14 days
Subgrouping and TBE
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.
Time frame: 1-14 days
The record gives a start of Jun 2011, a primary completion of Dec 2013 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Doxycycline · Penicillin V · Amoxicillin