Projects / Programmes
Duration of antibiotic treatment of erythema migrans
| Code |
Science |
Field |
Subfield |
| 3.01.00 |
Medical sciences |
Microbiology and immunology |
|
| Code |
Science |
Field |
| B007 |
Biomedical sciences |
Medicine (human and vertebrates) |
| Code |
Science |
Field |
| 3.02 |
Medical and Health Sciences |
Clinical medicine |
Lyme borreliosis; erythema migrans; doxycycline; treatment; duration of treatment; efficacy; safety
Researchers (9)
Organisations (1)
Abstract
Purpose of the work: 1. To compare the effectiveness and safety of the established, 15 day treatment of erythema migrans with oral doxycycline 100 mg twice a day with a shorter, 10 day duration of treatment with doxycycline in the same daily dose.
2. To assess the causal relationship between subjective symptoms identified by patients after appropriate erythema migrans treatment and prior Lyme borreliosis.
Hypothesis: 1. We assume that the 10 and 15 day treatment with oral doxycycline are equally effective and safe for treating erythema migrans.
2. We assume that subjective symptoms identified by patients after erythema migrans treatment are not causally related to borrelial infection.
Rationale: In several randomized studies assessing effectiveness of antibiotic treatment of erythema migrans, performed in Europe and the U.S.A., different antibiotics and different modes of dosing proved to be comparable and very effective: following the completion of appropriate antibiotic treatment, objective signs of Lyme borreliosis occurred only exceptionally. The effectiveness of the 10 day treatment with doxycycline in patients with erythema migrans was assessed in the U.S.A. but not in Europe. Since the clinical course of erythema migrans in Europe differs somewhat from that in the U.S.A. and since a direct comparison of the effectiveness of individual antibiotics for the treatment of erythema migrans between the U.S.A. and Europe has not been carried out, we can only assume there are no significant differences.
After completion of appropriate antibiotic treatment of erythema migrans, objective signs of late Lyme borreliosis occur only exceptionally, however subjective symptoms are not rare. Opinions on the causal relationship between subjective symptoms and the prior erythema migrans are divergent. Among the scientific articles published in English, we found only one prospective study on the effectiveness of erythema migrans treatment, which included a control group to assess and compare the frequency of subjective symptoms.
Methods: The effectiveness and safety of different duration of treatment with doxycycline will be compared according to clinical and microbiological parameters. We will analyse data on patients with erythema migrans, examined at the Lyme borreliosis outpatient clinic of University Medical Center Ljubljana in a 6 months period (from 1.6. to 30.11.). Patients will be treated with oral doxycycline 100 mg twice daily for 10 or 15 days. Clinical examination and laboratory tests will be performed at the first visit, and 14 days, 2, 6 and 12 months later. We will evaluate the speed of erythema migrans and subjective symptoms of early Lyme borreliosis disappearance and the frequency of later manifestations of Lyme borreliosis. In order to compare the frequency of nonspecific symptoms after erythema migrans treatment with the frequency of the same symptoms in general population, we will include a control group of subjects without a history of Lyme borreliosis.
Expected results: 10 and 15 day regimen of oral doxycycline are comparably effective and safe in treating adult patients with erythema migrans. The frequency of subjective symptoms after erythema migrans treatment is no different than the frequency of similar symptoms in control subjects without a history of Lyme borreliosis.
Significance for science
- Information not published in the literature has been obtained. - Large number of Borrelia isolates as well as stored serum and skin specimens are a good basis for later studies. Some of the gathered material was used in the study that resulted in a report published in high-ranked journal.
Significance for the country
- The finding that 10-day and 15-day duration of treatment were equally effective for the treatment of adult patients with erythema migrans according to clinical and microbiological parameters represents an appropriate scientific basis for shortening the duration of the established i.e. sofar recommended regimen of doxycycline, which is, in Europe and the U.S.A., 14 to 21 days. Shorter antibiotic therapy is less costly, has less side effects for treated individual, and is ecologically less harmful (smaller chances for the development of bacterial resistance). - The finding that the frequency of subjective symptoms after erythema migrans treatment is comparable to the frequency of the same symptoms in control subjects without a history of Lyme borreliosis directs the search toward other possible causes of subjective symptoms and more importantly justifiably discourage physicians from prescribing antibiotics for "treatment" of subjective symptoms that persist or appear after a properly treated erythema migrans.
Most important scientific results
Annual report
2010,
2011,
2012,
final report,
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Most important socioeconomically and culturally relevant results
Annual report
2010,
2011,
2012,
final report,
complete report on dLib.si
