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Trial record 47 of 73 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:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
No intervention.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
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

Locations
Slovenia
University Medical centzer Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324    dasa.stupica@kclj.si   
Contact: Maša Velušček, MD    +386 1 522 21 10    masa.veluscek@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia

Responsible Party: Daša Stupica, MD, PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03153267     History of Changes
Other Study ID Numbers: EM-Doxy714
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Lyme Disease
Erythema
Erythema Chronicum Migrans
Skin Diseases
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents