Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
Information source: Sorlandet Hospital HF
Information obtained from ClinicalTrials.gov on November 03, 2008 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lyme Neuroborreliosis
Intervention: Ceftriaxone (Drug); Doxycycline (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Sorlandet Hospital HF Official(s) and/or principal investigator(s): Åse Mygland, MD, PhD, Study Chair, Affiliation: Sorlandet Sykehus HF
Overall contact: Unn Ljøstad, MD, Phone: ++4738073910, Email: unn.ljostad@sshf.no
Summary
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the
treatment of neuroborreliosis in a randomized controlled trial.
Clinical Details
Official title: Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-Blind Comparison
Study design: Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Neurological symptoms and/or findings consistent with neuroborreliosis and at least
one of the following fulfilled:
- Intrathecal production of borrelia antibodies;
- White cell count in cerebrospinal fluid (CSF) > 5/mm3;
- Significant rise in borrelia antibodies in two serum samples collected from a
patient with at least 3 weeks interval;
- Verified acrodermatitis chronica atrophicans.
Exclusion Criteria:
- Allergy to the contents in the medication, or earlier type I reaction to penicillin.
- Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
- Pregnancy or breastfeeding
- Age < 18 years
Locations and Contacts
Unn Ljøstad, MD, Phone: ++4738073910, Email: unn.ljostad@sshf.no
Sørlandet Sykehus HF, Kristiansand, Vest-Agder 4633, Norway; Recruiting Svein Gunnar Gundersen, MD, PhD, Phone: ++4738073000, Email: s.g.gundersen@sshf.no Unn Ljøstad, MD, Principal Investigator
Additional Information
Starting date: March 2004
Last updated: December 14, 2005
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