Clinical trial NCT01635530: Study of Lyme Neuroborreliosis
Official title: Study of Lyme Neuroborreliosis: Epidemiology, Manifestations, Diagnostics and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lyme Neuroborreliosis
Keywords: doxycycline
ceftriaxone
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2012-07-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):

1. Neurological symptoms suggestive of LNB without other obvious reasons
2. CSF pleocytosis (\>4 leukocytes per mikrol)
3. Intrathecal production of B. burgdorferi specific antibodies
4. Detection of B. burgdorferi DNA in central spinal fluid

Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):

1. Neurological symptoms suggestive of LNB wihtout other obvious reasons
2. Production of B. burgdorferi spesific antibodies in serum
3. Erythema migrans during the previous three months

Exclusion Criteria:

* pregnancy and breastfeeding
* women planning to get pregnant in two months
* age under 18
* handicapped persons
* prisoners
* use of any antibiotics two weeks before study treatments begins
* allergy for tetracyclines or cephalosporins

Primary outcomes:
measure: The improvement of the clinical condition during the study.
timeFrame: 12 months
measure: The clinical condition evaluated by the participants after 12 months from the treatment
timeFrame: 12 months
Secondary outcomes:
measure: Central spinal fluid (CSF) pleocytosis
timeFrame: 3 weeks
measure: CSF protein concentration
timeFrame: 3 weeks
measure: CSF lactate level
timeFrame: 3 weeks
measure: CSF CXCL13 concentration
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: University of Turku
name: Jukka Hytönen
role: PRINCIPAL_INVESTIGATOR
affiliation: HYKS
name: Elisa Kortela
role: PRINCIPAL_INVESTIGATOR
affiliation: HYKS
name: Mari Kanerva
role: PRINCIPAL_INVESTIGATOR
affiliation: TYKS
name: Laura Airas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kortela E, Kanerva MJ, Puustinen J, Hurme S, Airas L, Lauhio A, Hohenthal U, Jalava-Karvinen P, Nieminen T, Finnila T, Haggblom T, Pietikainen A, Koivisto M, Vilhonen J, Marttila-Vaara M, Hytonen J, Oksi J. Oral Doxycycline Compared to Intravenous Ceftriaxone in the Treatment of Lyme Neuroborreliosis: A Multicenter, Equivalence, Randomized, Open-label Trial. Clin Infect Dis. 2021 Apr 26;72(8):1323-1331. doi: 10.1093/cid/ciaa217.