drugset / Trial / NCT01635530

Study of Lyme Neuroborreliosis

NCT01635530 ↗

Phase 4 Completed 210 enrolled Turku University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to determine whether four weeks treatment with oral doxycycline is as equally effective as three weeks treatment with intravenous ceftriaxone in patients with Lyme neuroborreliosis. The other purpose is to improve laboratory diagnostics of Lyme neuroborreliosis and further define the manifestations and epidemiology of the disease in Finland.

Timeline

Start
2012-08
Primary completion
2017-12-31
Completion
2018-12-31

Outcome

Met primary endpoint

paper mean difference, 0.17 [95% confidence interval, -.59 to .92], which is within the prespecified equivalence margins of -1 to 1 units PMID 32133487 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftriaxone Other / unclassified 2 g Intravenous
Subject Doxycycline Small molecule 100 mg Oral

Indications