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Trial record 7 of 37 for:    lyme AND Antibiotics

Duration of Antibiotic Treatment of Erythema Migrans

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ClinicalTrials.gov Identifier: NCT00910715
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : July 18, 2012
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Erythema Chronicum Migrans
Interventions Drug: doxycycline
Drug: placebo
Enrollment 306
Recruitment Details

Patients older than 15 years evaluated between June and October 2009 at the Lyme Borreliosis Outpatient Clinic, University Medical Center Ljubljana, Slovenia were eligible for the study if they had typical solitary erythema migrans as defined by CDC.

Patients were asked to refer a spouse/friend of the same age ± 5 years to serve as a control.

Pre-assignment Details 241 were evaluated for enrollment and not enrolled in the study.
Arm/Group Title EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Hide Arm/Group Description doxycycline 100 mg b.i.d. for 10 days doxycycline 100 b.i.d. for 15 days subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
Period Title: Overall Study
Started 108 117 81
Completed 86 91 81
Not Completed 22 26 0
Reason Not Completed
Lost to Follow-up             22             26             0
Arm/Group Title EM-10 Days Doxycycline EM-doxycycline 15 Days Controls Total
Hide Arm/Group Description doxycycline 100 mg b.i.d. for 10 days doxycycline 100 b.i.d. for 15 days subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point Total of all reporting groups
Overall Number of Baseline Participants 108 117 0 225
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 117 participants 0 participants 225 participants
<=18 years
2
   1.9%
2
   1.7%
4
   1.8%
Between 18 and 65 years
88
  81.5%
101
  86.3%
189
  84.0%
>=65 years
18
  16.7%
14
  12.0%
32
  14.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 108 participants 117 participants 0 participants 225 participants
52.5  (14.3) 49.6  (14.0) 50.4  (14.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 108 participants 117 participants 0 participants 225 participants
Female
62
  57.4%
63
  53.8%
125
  55.6%
Male
46
  42.6%
54
  46.2%
100
  44.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Slovenia Number Analyzed 108 participants 117 participants 0 participants 225 participants
108 117 225
1.Primary Outcome
Title Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
Hide Description At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.
Time Frame 1 year follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Number of participants with complete response to treatment.
Arm/Group Title EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Hide Arm/Group Description:
doxycycline 100 mg b.i.d. for 10 days
doxycycline 100 b.i.d. for 15 days
subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
Overall Number of Participants Analyzed 108 117 81
Measure Type: Number
Unit of Measure: number of participants
number of patients with complete response 79 85 81
number of patients with NOIS 7 6 NA [1] 
[1]
Controls were not subjected to any intervention and were therefore not aplicable for evaluation on treatment outcome.
2.Secondary Outcome
Title Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
Hide Description

6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, 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).

Time Frame 6 months after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
number of participants with nonspecific symptoms
Arm/Group Title EM Patients Controls
Hide Arm/Group Description:
EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
control subjects without a history of Lyme borreliosis
Overall Number of Participants Analyzed 197 81
Measure Type: Number
Unit of Measure: number of participants
151 60
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Hide Arm/Group Description doxycycline 100 mg b.i.d. for 10 days doxycycline 100 b.i.d. for 15 days subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
All-Cause Mortality
EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/108 (22.22%)      32/117 (27.35%)      0/0    
Gastrointestinal disorders       
Gastrointestinal symptoms, Photosensitivity  24/108 (22.22%)  32/117 (27.35%)  0/0  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
EM-10 Days Doxycycline EM-doxycycline 15 Days Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/108 (4.63%)      9/117 (7.69%)      0/0    
General disorders       
Sleepiness, headache, vaginal discharge, dizziness, nervousness, obstipation  5/108 (4.63%)  9/117 (7.69%)  0/0  0
sleepiness  3/108 (2.78%)  2/117 (1.71%)  0/0  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Dasa Stupica
Organization: UMC Ljubljana, Department of Infectious Diseases
Phone: +386 1 522 2110
Responsible Party: Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00910715     History of Changes
Other Study ID Numbers: EM-0509
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: October 5, 2011
Results First Posted: July 18, 2012
Last Update Posted: June 2, 2017