Study on Early Lyme Neuroborreliosis
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ClinicalTrials.gov Identifier: NCT00910533 |
Recruitment Status : Unknown
Verified May 2017 by Franc Strle, University Medical Centre Ljubljana.
Recruitment status was: Recruiting
First Posted : June 1, 2009
Last Update Posted : October 16, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nervous System Lyme Borreliosis | Drug: ceftriaxone | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Clinical and Microbiological Parameters in Patients With Early Lyme Neuroborreliosis |
Study Start Date : | January 1, 2009 |
Estimated Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Early Lyme neuroborreliosis patients |
Drug: ceftriaxone
ceftriaxone 2 g od i.v. for 14 days |
No Intervention: control subjects
Control subjects without a history of Lyme borreliosis.
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- Objective sequelae and post-treatment subjective symptoms in patients treated with ceftriaxone for early Lyme neuroborreliosis [ Time Frame: 1 year follow-up ]
- Comparison of subjective symptoms between patients treated with ceftriaxone for early Lyme neuroborreliosis and control subjects without a history of Lyme borreliosis [ Time Frame: 1 year follow-up ]

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old
Exclusion Criteria:
- pregnancy
- lactation
- history of adverse reaction to a beta-lactam antibiotic

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00910533
Contact: Dasa Stupica, MD | +38615222110 | cerar.dasa@gmail.com | |
Contact: Franc Strle, MD | +38615222110 | franc.strle@kclj.si |
Slovenia | |
UMC Ljubljana, Department of Infectious Diseases | Recruiting |
Ljubljana, Slovenia, 1525 | |
Contact: Dasa Stupica, MD +386 1 522 2110 cerar.dasa@gmail.com | |
Contact: Franc Strle, MD +386 1 5222610 franc.strle@kclj.si | |
Principal Investigator: Dasa Stupica, M.D., PhD | |
Sub-Investigator: Katarina Ogrinc, M.D., PhD | |
Sub-Investigator: Petra Bogovic, MD | |
Sub-Investigator: Eva Ruzic-Sabljic, M.D., PhD | |
Sub-Investigator: Tjasa Cerar, PhD |
Study Chair: | Franc Strle, MD | UMC Ljubljana |
Responsible Party: | Franc Strle, M.D., PhD, University Medical Centre Ljubljana |
ClinicalTrials.gov Identifier: | NCT00910533 |
Other Study ID Numbers: |
LNB-0509 |
First Posted: | June 1, 2009 Key Record Dates |
Last Update Posted: | October 16, 2018 |
Last Verified: | May 2017 |
Lyme neuroborreliosis |
Lyme Disease Lyme Neuroborreliosis Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections Spirochaetales Infections Tick-Borne Diseases |
Central Nervous System Bacterial Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents |