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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ceftriaxone | Active Comparator | Treatment of intravenous ceftriaxone (2 g/day), three weeks |
|
| Doxycycline | Experimental | Treatment with oral doxycycline (200mg / day), four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline: 100mg tablet two times per day, four weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of the clinical condition during the study. | The clinical condition of participants will be evaluated with visual analogue scale (from 0 to 10, 0=best) by the participants. The VAS scores are collected before the treatment with antibiotics, and 4 months and 12 months after the treatment. | 12 months |
| The clinical condition evaluated by the participants after 12 months from the treatment | The clinical condition is evaluated with VAS by the participants. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central spinal fluid (CSF) pleocytosis | The decline in CSF leukocyte count between the patients in doxycycline and ceftriaxone groups | 3 weeks |
| CSF protein concentration | The decline in CSF protein concentration between the patients in doxycycline and ceftriaxone groups. |
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Inclusion Criteria for definite Lyme neuroborreliosis (Criteria 1-3 or 1 and 4 fulfilled):
Inclusion Cirteria for possible LNB (criteria 1 and 2 or 3 fullfilled):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jukka Hytönen | University of Turku | Principal Investigator |
| Elisa Kortela | HYKS | Principal Investigator |
| Mari Kanerva | HYKS | Principal Investigator |
| Laura Airas | TYKS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland | |||
| Turku University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32133487 | Derived | 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. |
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| ID | Term |
|---|---|
| D020852 | Lyme Neuroborreliosis |
| ID | Term |
|---|---|
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Ceftriaxone |
| Drug |
2 g intravenous once a day, three weeks |
|
| 3 weeks |
| CSF lactate level | The decline in CSF lactate level between the patients in doxycycline and ceftriaxone groups. | 3 weeks |
| CSF CXCL13 concentration | The decline in CSF CXCL13 concentration wetween the patients in doxycycline and ceftriaxone groups | 3 weeks |
| Turku |
| 20521 |
| Finland |
| D008193 | Lyme Disease |
| D016905 | Gram-Negative Bacterial Infections |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D002494 | Central Nervous System Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |