Duration of Doxycycline Treatment in EM Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03153267|
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment|
|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.|
|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.
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
|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|