Recruiting NCT03337932
Duration of Doxycycline Treatment in MEM Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doxycycline 100 milligram Oral Tablet bid, 7 days, Doxycycline 100 milligram Oral Tablet bid, 14 days, Controls without a history of lyme disease..
- Who it may be relevant to
- Registry conditions: Erythema Chronicum Migrans. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
Overview
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.
Interventions
- Drug Doxycycline 100 milligram Oral Tablet bid, 7 days
Patients will receive doxycycline for 7 days. - Drug Doxycycline 100 milligram Oral Tablet bid, 14 days
Patients will receive doxycycline for 14 days. - Drug Controls without a history of lyme disease.
No intervention.
Primary outcome measures
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [Time frame: Study point: at 14 days post-enrollment.]
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [Time frame: Study point: at 2 months post-enrollment.]
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [Time frame: Study point: at 6 months post-enrollment.]
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [Time frame: Study point: at 12 months post-enrollment.]
Secondary outcome measures (1)
- Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with multiple erythema migrans and control subjects [Time frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment.]
Eligibility criteria
Inclusion criteria
- multiple erythema migrans
Exclusion criteria
- pregnancy or lactation
- immunocompromised
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- extracutaneous manifestations of lyme borreliosis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 1 center
- University Medical center Ljubljana — Ljubljana
Identifiers
NCT: NCT03337932 · MEM-Doxy