Duration of Doxycycline Treatment in EM Patients

Erythema Chronicum Migrans Clinical Trial

Official title:

Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03153267
• Other study ID #: EM-Doxy714
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• solitary erythema migrans

Exclusion Criteria:

• pregnancy or lactation

• immunocompromised

• serious adverse event to doxycycline

• taking antibiotic with antiborrelial activity within 10 days

• multiple erythema migrans or extracutaneous manifestations of lyme borreliosis

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans

Intervention

Drug:
• Doxycycline 100 MG Oral Tablet bid, 7 days
Patients will receive doxycycline for 7 days.
• Doxycycline 100 MG Oral Tablet bid, 14 days
Patients will receive doxycycline for 14 days.
• Controls without a history of lyme disease.
No intervention.

Locations

Country	Name	City	State
Slovenia	University Medical centzer Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days	Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.	At 12 months after enrollment.
Secondary	Comparison of nonspecific symptoms in patients with erythema migrans and control subjects	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.	At 12 months after enrollment.