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Trial record 44 of 64 for:    lyme

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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

March 16, 2017
May 15, 2017
December 5, 2017
June 1, 2017
June 30, 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT03153267 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Duration of Doxycycline Treatment in EM Patients
Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Erythema Chronicum Migrans
  • Drug: Doxycycline 100 MG Oral Tablet bid, 7 days
    Patients will receive doxycycline for 7 days.
  • Drug: Doxycycline 100 MG Oral Tablet bid, 14 days
    Patients will receive doxycycline for 14 days.
  • Drug: Controls without a history of lyme disease.
    No intervention.
  • Active Comparator: EM-7 days doxycycline
    Intervention: Drug: Doxycycline 100 MG Oral Tablet bid, 7 days
  • Active Comparator: EM-14 days doxycycline
    Intervention: Drug: Doxycycline 100 MG Oral Tablet bid, 14 days
  • Placebo Comparator: Controls
    Intervention: Drug: Controls without a history of lyme disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
June 30, 2020
June 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Daša Stupica, MD PhD + 386 1 522 21 10 dasa.stupica@kclj.si
Contact: Franc Strle, MD PhD + 386 1 522 21 10 franc.strle@kclj.si
Slovenia
 
 
NCT03153267
EM-Doxy714
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
Daša Stupica, University Medical Centre Ljubljana
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Not Provided
University Medical Centre Ljubljana
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP