Trial Outcomes & Findings for Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome (NCT NCT01518192)

Results Overview

Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

544 participants

Primary outcome timeframe

at 14 days post inclusion

Results posted on

2012-01-25

Participant Flow

Adult patients with typical erythema migrans, examined in the period from June to September 2006 at Lyme Disease Outpatient Clinic, University Medical Center Ljubljana, Slovenia

113/398 patients were ineligible due to: * receiving antibiotic with known anti-borrelial activity (73) * multiple erythema migrans (16) * history of Lyme disease (12) * immunocompromising condition (4) * serious adverse reaction to study drugs (3) * pregnancy or lactation (4) * erythema migrans accompanied by meningitis (1)

Participant milestones

Participant milestones
Measure	Doxycycline Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.	Cefuroxime Axetil Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.	Controls patients' family members or friends without a history of Lyme disease
Overall Study STARTED	145	140	259
Overall Study COMPLETED	116	114	224
Overall Study NOT COMPLETED	29	26	35

Reasons for withdrawal

Reasons for withdrawal
Measure	Doxycycline Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.	Cefuroxime Axetil Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily. At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture.	Controls patients' family members or friends without a history of Lyme disease
Overall Study Lost to Follow-up	29	26	35

Baseline Characteristics

Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Doxycycline n=145 Participants Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week. Evaluations: At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture.	Cefuroxime Axetil n=140 Participants Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week. Evaluations: At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture.	Controls n=259 Participants To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.	Total n=544 Participants Total of all reporting groups
Age Continuous	54 years FULL_RANGE 14.6 • n=5 Participants	51.5 years FULL_RANGE 14.9 • n=7 Participants	52 years n=5 Participants	52.5 years FULL_RANGE 14.9 • n=4 Participants
Sex: Female, Male Female	84 Participants n=5 Participants	77 Participants n=7 Participants	125 Participants n=5 Participants	286.0 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	63 Participants n=7 Participants	134 Participants n=5 Participants	258.0 Participants n=4 Participants
Region of Enrollment Slovenia	145 participants n=5 Participants	140 participants n=7 Participants	259 participants n=5 Participants	544.0 participants n=4 Participants

PRIMARY outcome

Timeframe: at 14 days post inclusion

Population: All participants who followed the protocol were eligible for analysis

Number of patients with objective manifestations of Lyme disease(persistence of erythema migrans or any of the extracutaneous-cardiac, nervous or skeletal-Lyme disease manifestations)and/or with post-Lyme disease symptoms in patients treated for solitary erythema migrans at 14 days post inclusion

Outcome measures

Outcome measures
Measure	Doxycycline n=145 Participants doxycycline 100 mg twice daily for 15 days	Cefuroxime Axetil n=140 Participants cefuroxime axetil 500 mg twice daily for 15 days
Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days	30 participants	27 participants

PRIMARY outcome

Timeframe: at 14 days

Population: All participants who followed the protocol.

Number of patients reporting adverse events