Trial Outcomes & Findings for Duration of Antibiotic Treatment of Erythema Migrans (NCT NCT00910715)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

306 participants

Primary outcome timeframe

1 year follow-up

Results posted on

2017-06-02

Participant Flow

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.

241 were evaluated for enrollment and not enrolled in the study.

Participant milestones

Participant milestones
Measure	EM-10 Days Doxycycline doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days doxycycline 100 b.i.d. for 15 days	Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
Overall Study STARTED	108	117	81
Overall Study COMPLETED	86	91	81
Overall Study NOT COMPLETED	22	26	0

Reasons for withdrawal

Reasons for withdrawal
Measure	EM-10 Days Doxycycline doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days doxycycline 100 b.i.d. for 15 days	Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
Overall Study Lost to Follow-up	22	26	0

Baseline Characteristics

Duration of Antibiotic Treatment of Erythema Migrans

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EM-10 Days Doxycycline n=108 Participants doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days n=117 Participants doxycycline 100 b.i.d. for 15 days	Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point	Total n=225 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	2 Participants n=7 Participants	—	4 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	88 Participants n=5 Participants	101 Participants n=7 Participants	—	189 Participants n=4 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	14 Participants n=7 Participants	—	32 Participants n=4 Participants
Age, Continuous	52.5 years STANDARD_DEVIATION 14.3 • n=5 Participants	49.6 years STANDARD_DEVIATION 14.0 • n=7 Participants	—	50.4 years STANDARD_DEVIATION 14.9 • n=4 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	63 Participants n=7 Participants	—	125 Participants n=4 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	54 Participants n=7 Participants	—	100 Participants n=4 Participants
Region of Enrollment Slovenia	108 participants n=5 Participants	117 participants n=7 Participants	—	225 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 year follow-up

Population: Number of participants with complete response to treatment.

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.

Outcome measures

Outcome measures
Measure	EM-10 Days Doxycycline n=108 Participants doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days n=117 Participants doxycycline 100 b.i.d. for 15 days	Controls n=81 Participants 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
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. number of patients with complete response	79 number of participants	85 number of participants	81 number of participants
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. number of patients with NOIS	7 number of participants	6 number of participants	NA number of participants Controls were not subjected to any intervention and were therefore not aplicable for evaluation on treatment outcome.

SECONDARY outcome

Timeframe: 6 months after treatment

Population: number of participants with nonspecific symptoms

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).

Outcome measures

Outcome measures
Measure	EM-10 Days Doxycycline n=197 Participants doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days n=81 Participants doxycycline 100 b.i.d. for 15 days	Controls 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
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.	151 number of participants	60 number of participants	—

Adverse Events

EM-10 Days Doxycycline

Serious events: 24 serious events

Other events: 5 other events

Deaths: 0 deaths

EM-doxycycline 15 Days

Serious events: 32 serious events

Other events: 9 other events

Deaths: 0 deaths

Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EM-10 Days Doxycycline n=108 participants at risk doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days n=117 participants at risk doxycycline 100 b.i.d. for 15 days	Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
Gastrointestinal disorders Gastrointestinal symptoms, Photosensitivity	22.2% 24/108	27.4% 32/117	— 0/0

Other adverse events

Other adverse events
Measure	EM-10 Days Doxycycline n=108 participants at risk doxycycline 100 mg b.i.d. for 10 days	EM-doxycycline 15 Days n=117 participants at risk doxycycline 100 b.i.d. for 15 days	Controls subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
General disorders Sleepiness, headache, vaginal discharge, dizziness, nervousness, obstipation	4.6% 5/108	7.7% 9/117	— 0/0
General disorders sleepiness	2.8% 3/108	1.7% 2/117	— 0/0

Additional Information

Dr.Dasa Stupica

UMC Ljubljana, Department of Infectious Diseases

Phone: +386 1 522 2110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place