An interventional study of doxycycline and doxycycline in Erythema Chronicum Migrans, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-02.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Other
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.
This study's enrollment of 306 is above the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.
Browse Glossitis, Benign Migratory studies →University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: doxycycline
Drug: doxycycline
Drug: placebo
doxycycline 100 mg bid, 10 days
doxycycline 100 mg bid, 15 days
control subjects without a history of Lyme borreliosis
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.
Time frame: 1 year follow-up
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).
Time frame: 6 months after treatment
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.
| Milestone | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls |
|---|---|---|---|
| Started | 108 | 117 | 81 |
| Completed | 86 | 91 | 81 |
| Not completed | 22 | 26 | 0 |
| Withdrew: Lost to follow-up | 22 | 26 | 0 |
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 | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls |
|---|---|---|---|
| number of patients with complete response | 79 | 85 | 81 |
| number of patients with NOIS | 7 | 6 | NA |
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 | EM Patients | Controls |
|---|---|---|
| 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 | 60 |
Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EM-10 Days Doxycycline | — | 24/108 (22.2%) | 5/108 (4.6%) |
| EM-doxycycline 15 Days | — | 32/117 (27.4%) | 9/117 (7.7%) |
| Controls | — | — | — |
| Event | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls |
|---|---|---|---|
| Gastrointestinal symptoms, PhotosensitivityGastrointestinal disorders | 24/108 | 32/117 | — |
| Event | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls |
|---|---|---|---|
| Sleepiness, headache, vaginal discharge, dizziness, nervousness, obstipationGeneral disorders | 5/108 | 9/117 | — |
| sleepinessGeneral disorders | 3/108 | 2/117 | — |
| Age, Categorical(Participants) | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls | Total |
|---|---|---|---|---|
| <=18 years | 2 | 2 | — | 4 |
| Between 18 and 65 years | 88 | 101 | — | 189 |
| >=65 years | 18 | 14 | — | 32 |
| Age, Continuous(years) | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls | Total |
|---|---|---|---|---|
| Mean | 52.5 ± 14.3 | 49.6 ± 14.0 | — | 50.4 ± 14.9 |
| Sex: Female, Male(Participants) | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls | Total |
|---|---|---|---|---|
| Female | 62 | 63 | — | 125 |
| Male | 46 | 54 | — | 100 |
| Region of Enrollment(participants) | EM-10 Days Doxycycline | EM-doxycycline 15 Days | Controls | Total |
|---|---|---|---|---|
| Slovenia | 108 | 117 | — | 225 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Doxycycline
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