Duration of Doxycycline Treatment in EM Patients
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|ClinicalTrials.gov Identifier: NCT03153267|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : April 22, 2019
|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 :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153267
|University Medical centzer Ljubljana|
|Principal Investigator:||Daša Stupica, MD PhD||University Mecical Centre Ljubljana|