EUCTR2015-001481-25-NOActive, not recruitingPhase 1
yme borreliosis; a scientific approach to reduce diagnostic and therapeutic uncertainties (BorrSci)WP2; SIX VERSUS TWO WEEKS TREATMENT WITH DOXYCYCLINE IN LYME NEUROBORRELIOSIS; A MULTICENTER, NON-INFERIORITY, PENTA-BLIND, RANDOMIZED TRIAL - BorrSciWP2
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Sørlandet Sykehus HF
- Enrollment
- 250
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Neurological symptoms suggestive of LNB without other obvious reasons and one or both of
- •a .Cerebrospinal fluid pleocytosis (>5 leukocytes/mm3)
- •b. Intrathecal Bb antibody production
- •2.Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
Exclusion Criteria
- •-?Age less than 18 years
- •-?Pregnancy, breast-feeding
- •-?Adverse reaction to tetracyclines
- •-?Treatment with cephalosporin, penicillin, or tetracycline the last 14 days
- •-?Serious liver or kidney disease that contraindicates use of doxycyline
- •-?Lactose intolerance
- •- Need to use medications contraindicated according to SmPC of the IMP
Investigators
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