Comparison of two and six weeks treatment with doxycyline in neuroborreliosis

Phase 1

• Conditions: yme Neuroborreliosis; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2015-001481-25-NO
• Lead Sponsor: Sørlandet Sykehus HF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-27
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified