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Trial record 42 of 74 for:    lyme

Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans

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ClinicalTrials.gov Identifier: NCT03584919
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

Brief Summary:
A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).

Condition or disease Intervention/treatment Phase
Erythema Chronicum Migrans Drug: doxycycline Drug: Cefuroxime Axetil 500Mg Tab Other: control subjects Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 509 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans
Actual Study Start Date : June 1, 2006
Actual Primary Completion Date : September 30, 2007
Actual Study Completion Date : September 30, 2007


Arm Intervention/treatment
Active Comparator: EM doxycycline
patients with EM who received doxycycline
Drug: doxycycline
patients received oral doxycycline 100 milgrams bid for 15 days

Active Comparator: EM cefuroxime axetil
patients with EM who received cefuroxime axetil
Drug: Cefuroxime Axetil 500Mg Tab
patients received cefuroxime axetil 500 milgrams bid for 15 days

Placebo Comparator: controls
control subjects without history of Lyme disease
Other: control subjects
no intervention




Primary Outcome Measures :
  1. Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days [ Time Frame: One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment) ]
    At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.


Secondary Outcome Measures :
  1. Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms. [ Time Frame: 12 months after treatment ]
    12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, concentration difficulties, or irritability) within the preceding week. For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion <5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

Exclusion Criteria:

  • Lyme disease previously
  • pregnancy or lactation
  • immunocompromised
  • serious adverse reaction to a beta-lactam or tetracycline drug in the past
  • received an antibiotic with known anti-borrelial activity within 10 days
  • multiple erythema migrans lesions
  • presence of an extracutaneous manifestation of Lyme disease

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03584919     History of Changes
Other Study ID Numbers: Doxy-Zinnat
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lyme Disease
Erythema
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Cefuroxime
Cefuroxime axetil
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents