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The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EM-10 days doxycycline | Active Comparator |
| |
| EM-doxycycline 15 days | Active Comparator |
| |
| controls | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doxycycline | Drug | doxycycline 100 mg bid, 10 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. | 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. | 1 year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Franc Strle, MD | UMC Ljubljana | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Ljubljana, Department of Infectious Diseases | Ljubljana | 1525 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30075748 | Derived | Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y. | |
| 22523260 | Derived | Stupica D, Lusa L, Ruzic-Sabljic E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. doi: 10.1093/cid/cis402. Epub 2012 Apr 20. |
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241 were evaluated for enrollment and not enrolled in the study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | EM-10 Days Doxycycline | doxycycline 100 mg b.i.d. for 10 days |
| FG001 | EM-doxycycline 15 Days | doxycycline 100 b.i.d. for 15 days |
| FG002 | Controls | subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EM-10 Days Doxycycline | doxycycline 100 mg b.i.d. for 10 days |
| BG001 | EM-doxycycline 15 Days | doxycycline 100 b.i.d. for 15 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. | 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. | Number of participants with complete response to treatment. | Posted | Number | number of participants | 1 year follow-up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EM-10 Days Doxycycline | doxycycline 100 mg b.i.d. for 10 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal symptoms, Photosensitivity | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sleepiness, headache, vaginal discharge, dizziness, nervousness, obstipation | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Dasa Stupica | UMC Ljubljana, Department of Infectious Diseases | +386 1 522 2110 | cerar.dasa@gmail.com |
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| ID | Term |
|---|---|
| D015787 | Erythema Chronicum Migrans |
| D005929 | Glossitis, Benign Migratory |
| D008193 | Lyme Disease |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| doxycycline |
| Drug |
doxycycline 100 mg bid, 15 days |
|
| placebo | Drug | control subjects without a history of Lyme borreliosis |
|
| 6 months after treatment |
| BG002 | Controls | subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | EM-doxycycline 15 Days | doxycycline 100 b.i.d. for 15 days |
| OG002 | 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 |
|
|
| Secondary | 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. | 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). | number of participants with nonspecific symptoms | Posted | Number | number of participants | 6 months after treatment |
|
|
|
| 24 |
| 108 |
| 5 |
| 108 |
| EG001 | EM-doxycycline 15 Days | doxycycline 100 b.i.d. for 15 days | 32 | 117 | 9 | 117 |
| EG002 | Controls | subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point | 0 | 0 | 0 | 0 |
| sleepiness | General disorders |
|
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| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017192 | Skin Diseases, Bacterial |
| D012874 | Skin Diseases, Infectious |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D004890 | Erythema |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005928 | Glossitis |
| D014060 | Tongue Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |