N/A
N=306
Duration of Antibiotic Treatment of Erythema Migrans
Erythema Chronicum Migrans
Bottom Line
View on ClinicalTrials.gov: NCT00910715 ↗Enrolled (actual)
306
Serious AEs
24.9%
Results posted
Jul 2012
Primary outcome: 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. — 79; 85; 81; 7 number of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- doxycycline (Drug); placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- University Medical Centre Ljubljana
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
79; 85; 81; 7; 6; NA | — |
| 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. |
151; 60 | — |
Summary
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
Eligibility Criteria
Inclusion Criteria
- solitary erythema migrans in patients > 15 years
Exclusion Criteria
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline
- taking antibiotic with antiborrelial activity within 10 days
- multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
Data sourced from ClinicalTrials.gov (NCT00910715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.