Duration of Doxycycline Treatment in EM Patients
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|ClinicalTrials.gov Identifier: NCT03153267|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Erythema Chronicum Migrans||Drug: Doxycycline 100 MG Oral Tablet bid, 7 days Drug: Doxycycline 100 MG Oral Tablet bid, 14 days Drug: Controls without a history of lyme disease.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.|
|Actual Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2020|
|Active Comparator: EM-7 days doxycycline||
Drug: Doxycycline 100 MG Oral Tablet bid, 7 days
Patients will receive doxycycline for 7 days.
|Active Comparator: EM-14 days doxycycline||
Drug: Doxycycline 100 MG Oral Tablet bid, 14 days
Patients will receive doxycycline for 14 days.
|Placebo Comparator: Controls||
Drug: Controls without a history of lyme disease.
- Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days [ Time Frame: At 12 months after enrollment. ]Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.
- Comparison of nonspecific symptoms in patients with erythema migrans and control subjects [ Time Frame: At 12 months after enrollment. ]Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153267
|Contact: Daša Stupica, MD PhD||+ 386 1 522 21 firstname.lastname@example.org|
|Contact: Franc Strle, MD PhD||+ 386 1 522 21 email@example.com|
|University Medical centzer Ljubljana||Recruiting|
|Contact: Daša Stupica, MD, PhD +386 31 689 324 firstname.lastname@example.org|
|Contact: Maša Velušček, MD +386 1 522 21 10 email@example.com|