Session Type: ePosters
Session Title: ePosters
Authors(s): M. Velušcek (1), A. Gomišcek (1), R. Blagus (2), T. Cerar Kišek (3), K. Boršic (1), M. Nahtigal Klevišar (1), E. Ružic Sabljic (3), D. Stupica (4)
Authors Affiliations(s): (1) Department of Infectious Diseases, University Medical Centre Ljubljana, Ljubljana, Slovenia, Slovenia, (2) Institute for Biostatistics and Medical Informatics, Faculty of Medicine Ljubljana, Vrazov trg 2, 1104 Ljubljana, Slovenia and Faculty of Sports, University of Ljubljana, Gortanova 22, 1000 Ljubljana, Slovenia, Slovenia, (3) Institute of Microbiology and Immunology, Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia, (4) Department of Infectious Diseases, University Medical Centre Ljubljana and Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia
Background:
With awareness of increasing bacterial resistance globally, it is important to re-evaluate the duration of therapies needed for particular infections. Doxycycline for 10 days is the shortest treatment duration recommended for adult patients with erythema migrans, but shorter regimens have not been assessed.
Methods:In an open-label randomized clinical trial, performed at the University Medical Centre Ljubljana, Slovenia, the efficacies of 7-day versus 14-day of oral doxycycline therapy were compared on a noninferiority premise in adult patients with solitary erythema migrans. The efficacy of treatment was assessed based on clinical and microbiologic parameters, assessed at 14 days and at 2, 6, and 12 months after enrolment.
Results:Out of 300 randomized patients, 147 patients (50.5%) completed treatment with doxycycline for 7 days, and 144 patients (49.5%) received doxycycline for 14 days. Patients in the two treatment groups did not differ regarding basic demographic, clinical, and microbiologic characteristics at enrolment. The proportion of patients with incomplete response decreased during follow-up, and was comparable between 7-day and 14-day treatment groups (14 days: 25/144 [17.4%] vs 29/141 [20.6%]; P=0.295; 2 months: 27/136 [19.9%] vs 23/132 [17.4%]; P=0.638; 6 months: 15/118 [12.7%] vs 14/124 [11.3%]; P=0.557). At the 12-month visit, 8/101 [7.9%] patients in the 7-day vs 9/102 [8.8%] patients in the 14-day group showed incomplete response (difference -0.9 percentage points; 1-sided 95% CI, –1 to 0.06 percentage points; P=0.5). None of the patients developed new objective manifestations of Lyme borreliosis during follow-up and none had positive skin re-biopsy culture result for borreliae.
Conclusions:The 7-day regimen of oral doxycycline was noninferior to the 14-day regimen for treating adult European patients with solitary erythema migrans. At 12 months post-enrolment, only a minority of patients had incomplete response, manifested as post-Lyme borreliosis symptoms.
Keyword(s): erythema migrans, doxycycline treatment, post-Lyme borreliosis symptomsCOI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Velušcek (1), A. Gomišcek (1), R. Blagus (2), T. Cerar Kišek (3), K. Boršic (1), M. Nahtigal Klevišar (1), E. Ružic Sabljic (3), D. Stupica (4)
Authors Affiliations(s): (1) Department of Infectious Diseases, University Medical Centre Ljubljana, Ljubljana, Slovenia, Slovenia, (2) Institute for Biostatistics and Medical Informatics, Faculty of Medicine Ljubljana, Vrazov trg 2, 1104 Ljubljana, Slovenia and Faculty of Sports, University of Ljubljana, Gortanova 22, 1000 Ljubljana, Slovenia, Slovenia, (3) Institute of Microbiology and Immunology, Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia, (4) Department of Infectious Diseases, University Medical Centre Ljubljana and Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia
Background:
With awareness of increasing bacterial resistance globally, it is important to re-evaluate the duration of therapies needed for particular infections. Doxycycline for 10 days is the shortest treatment duration recommended for adult patients with erythema migrans, but shorter regimens have not been assessed.
Methods:In an open-label randomized clinical trial, performed at the University Medical Centre Ljubljana, Slovenia, the efficacies of 7-day versus 14-day of oral doxycycline therapy were compared on a noninferiority premise in adult patients with solitary erythema migrans. The efficacy of treatment was assessed based on clinical and microbiologic parameters, assessed at 14 days and at 2, 6, and 12 months after enrolment.
Results:Out of 300 randomized patients, 147 patients (50.5%) completed treatment with doxycycline for 7 days, and 144 patients (49.5%) received doxycycline for 14 days. Patients in the two treatment groups did not differ regarding basic demographic, clinical, and microbiologic characteristics at enrolment. The proportion of patients with incomplete response decreased during follow-up, and was comparable between 7-day and 14-day treatment groups (14 days: 25/144 [17.4%] vs 29/141 [20.6%]; P=0.295; 2 months: 27/136 [19.9%] vs 23/132 [17.4%]; P=0.638; 6 months: 15/118 [12.7%] vs 14/124 [11.3%]; P=0.557). At the 12-month visit, 8/101 [7.9%] patients in the 7-day vs 9/102 [8.8%] patients in the 14-day group showed incomplete response (difference -0.9 percentage points; 1-sided 95% CI, –1 to 0.06 percentage points; P=0.5). None of the patients developed new objective manifestations of Lyme borreliosis during follow-up and none had positive skin re-biopsy culture result for borreliae.
Conclusions:The 7-day regimen of oral doxycycline was noninferior to the 14-day regimen for treating adult European patients with solitary erythema migrans. At 12 months post-enrolment, only a minority of patients had incomplete response, manifested as post-Lyme borreliosis symptoms.
Keyword(s): erythema migrans, doxycycline treatment, post-Lyme borreliosis symptomsCOI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Velušcek (1), A. Gomišcek (1), R. Blagus (2), T. Cerar Kišek (3), K. Boršic (1), M. Nahtigal Klevišar (1), E. Ružic Sabljic (3), D. Stupica (4)
Authors Affiliations(s): (1) Department of Infectious Diseases, University Medical Centre Ljubljana, Ljubljana, Slovenia, Slovenia, (2) Institute for Biostatistics and Medical Informatics, Faculty of Medicine Ljubljana, Vrazov trg 2, 1104 Ljubljana, Slovenia and Faculty of Sports, University of Ljubljana, Gortanova 22, 1000 Ljubljana, Slovenia, Slovenia, (3) Institute of Microbiology and Immunology, Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia, (4) Department of Infectious Diseases, University Medical Centre Ljubljana and Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia
Background:
With awareness of increasing bacterial resistance globally, it is important to re-evaluate the duration of therapies needed for particular infections. Doxycycline for 10 days is the shortest treatment duration recommended for adult patients with erythema migrans, but shorter regimens have not been assessed.
Methods:In an open-label randomized clinical trial, performed at the University Medical Centre Ljubljana, Slovenia, the efficacies of 7-day versus 14-day of oral doxycycline therapy were compared on a noninferiority premise in adult patients with solitary erythema migrans. The efficacy of treatment was assessed based on clinical and microbiologic parameters, assessed at 14 days and at 2, 6, and 12 months after enrolment.
Results:Out of 300 randomized patients, 147 patients (50.5%) completed treatment with doxycycline for 7 days, and 144 patients (49.5%) received doxycycline for 14 days. Patients in the two treatment groups did not differ regarding basic demographic, clinical, and microbiologic characteristics at enrolment. The proportion of patients with incomplete response decreased during follow-up, and was comparable between 7-day and 14-day treatment groups (14 days: 25/144 [17.4%] vs 29/141 [20.6%]; P=0.295; 2 months: 27/136 [19.9%] vs 23/132 [17.4%]; P=0.638; 6 months: 15/118 [12.7%] vs 14/124 [11.3%]; P=0.557). At the 12-month visit, 8/101 [7.9%] patients in the 7-day vs 9/102 [8.8%] patients in the 14-day group showed incomplete response (difference -0.9 percentage points; 1-sided 95% CI, –1 to 0.06 percentage points; P=0.5). None of the patients developed new objective manifestations of Lyme borreliosis during follow-up and none had positive skin re-biopsy culture result for borreliae.
Conclusions:The 7-day regimen of oral doxycycline was noninferior to the 14-day regimen for treating adult European patients with solitary erythema migrans. At 12 months post-enrolment, only a minority of patients had incomplete response, manifested as post-Lyme borreliosis symptoms.
Keyword(s): erythema migrans, doxycycline treatment, post-Lyme borreliosis symptomsCOI Institutional Grants: Yes
Session Type: ePosters
Session Title: ePosters
Authors(s): M. Velušcek (1), A. Gomišcek (1), R. Blagus (2), T. Cerar Kišek (3), K. Boršic (1), M. Nahtigal Klevišar (1), E. Ružic Sabljic (3), D. Stupica (4)
Authors Affiliations(s): (1) Department of Infectious Diseases, University Medical Centre Ljubljana, Ljubljana, Slovenia, Slovenia, (2) Institute for Biostatistics and Medical Informatics, Faculty of Medicine Ljubljana, Vrazov trg 2, 1104 Ljubljana, Slovenia and Faculty of Sports, University of Ljubljana, Gortanova 22, 1000 Ljubljana, Slovenia, Slovenia, (3) Institute of Microbiology and Immunology, Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia, (4) Department of Infectious Diseases, University Medical Centre Ljubljana and Faculty of Medicine Ljubljana, Ljubljana, Slovenia, Slovenia
Background:
With awareness of increasing bacterial resistance globally, it is important to re-evaluate the duration of therapies needed for particular infections. Doxycycline for 10 days is the shortest treatment duration recommended for adult patients with erythema migrans, but shorter regimens have not been assessed.
Methods:In an open-label randomized clinical trial, performed at the University Medical Centre Ljubljana, Slovenia, the efficacies of 7-day versus 14-day of oral doxycycline therapy were compared on a noninferiority premise in adult patients with solitary erythema migrans. The efficacy of treatment was assessed based on clinical and microbiologic parameters, assessed at 14 days and at 2, 6, and 12 months after enrolment.
Results:Out of 300 randomized patients, 147 patients (50.5%) completed treatment with doxycycline for 7 days, and 144 patients (49.5%) received doxycycline for 14 days. Patients in the two treatment groups did not differ regarding basic demographic, clinical, and microbiologic characteristics at enrolment. The proportion of patients with incomplete response decreased during follow-up, and was comparable between 7-day and 14-day treatment groups (14 days: 25/144 [17.4%] vs 29/141 [20.6%]; P=0.295; 2 months: 27/136 [19.9%] vs 23/132 [17.4%]; P=0.638; 6 months: 15/118 [12.7%] vs 14/124 [11.3%]; P=0.557). At the 12-month visit, 8/101 [7.9%] patients in the 7-day vs 9/102 [8.8%] patients in the 14-day group showed incomplete response (difference -0.9 percentage points; 1-sided 95% CI, –1 to 0.06 percentage points; P=0.5). None of the patients developed new objective manifestations of Lyme borreliosis during follow-up and none had positive skin re-biopsy culture result for borreliae.
Conclusions:The 7-day regimen of oral doxycycline was noninferior to the 14-day regimen for treating adult European patients with solitary erythema migrans. At 12 months post-enrolment, only a minority of patients had incomplete response, manifested as post-Lyme borreliosis symptoms.
Keyword(s): erythema migrans, doxycycline treatment, post-Lyme borreliosis symptomsCOI Institutional Grants: Yes