An interventional study of doxycycline and Cefuroxime Axetil 500Mg Tab in Erythema Chronicum Migrans, sponsored by University Medical Centre Ljubljana. Completed. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment
A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).
University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
patients with EM who received doxycycline
Drug: doxycycline
patients with EM who received cefuroxime axetil
Drug: Cefuroxime Axetil 500Mg Tab
control subjects without history of Lyme disease
Other: control subjects
patients received oral doxycycline 100 milgrams bid for 15 days
patients received cefuroxime axetil 500 milgrams bid for 15 days
no intervention
Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days
At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.
Time frame: One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)
Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, 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: 12 months after treatment
No study locations are listed for this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Doxycycline · Cefuroxime axetil
Erythema Chronicum Migrans
University Medical Centre Ljubljana →