Lyme NeuroborreliosisPhase 3NCT00138801
Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis
A Phase 3 study testing Ceftriaxone and Doxycycline in people with Lyme Neuroborreliosis, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lyme Neuroborreliosis
- What is being tested?
- Ceftriaxone and Doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2004to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:
- Intrathecal production of borrelia antibodies;
- White cell count in cerebrospinal fluid (CSF) > 5/mm3;
- Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval;
- Verified acrodermatitis chronica atrophicans.
Who cannot join
- Allergy to the contents in the medication, or earlier type I reaction to penicillin.
- Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
- Pregnancy or breastfeeding
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.
- Conditions
- Lyme Neuroborreliosis
- Being tested
- Ceftriaxone, Doxycycline
- Keywords
- Neuroborreliosis
- Medical subject headings
- Lyme Neuroborreliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftriaxoneDrug
DoxycyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Doxycycline Receives: Drug: Doxycycline |
| 2 | Active comparator | cephtriaxone Receives: Drug: Ceftriaxone |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionMar 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lyme NeuroborreliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Åse Mygland, MD, PhD, Study chair, Sorlandet Sykehus HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138801
- Sponsor's protocol ID
- SSHF813204
- Status last verified
- Mar 2005
- First submitted
- 29 Aug 2005
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Ljostad U, Skogvoll E, Eikeland R, Midgard R, Skarpaas T, Berg A, Mygland A. Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial. Lancet Neurol. 2008 Aug;7(8):690-5. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21.
PubMed 18567539
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Ceftriaxone and Oral Doxycycline for Lyme Neuroborreliosis. A Randomized Double-blind Comparison
- ClinicalTrials.gov ID
- NCT00138801
- Acronym / sponsor ID
- SSHF813204
- Conditions
- Lyme Neuroborreliosis
- Keywords
- Neuroborreliosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Mar 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare parenteral ceftriaxone and oral doxycycline in the treatment of neuroborreliosis in a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DoxycyclineDoxycycline |
| 2 | Active comparator | Drug: Ceftriaxonecephtriaxone |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled:
Key exclusion criteria (4 listed)
- Allergy to the contents in the medication, or earlier type I reaction to penicillin.
- Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days
- Pregnancy or breastfeeding
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ceftriaxone | Drug | 2 |
| Doxycycline | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Derived from this study: PubMed 18567539Ljostad U, Skogvoll E, Eikeland R, Midgard R, Skarpaas T, Berg A, Mygland A. Oral doxycycline versus intravenous ceftriaxone for European Lyme neuroborreliosis: a multicentre, non-inferiority, double-blind, randomised trial. Lancet Neurol. 2008 Aug;7(8):690-5. doi: 10.1016/S1474-4422(08)70119-4. Epub 2008 Jun 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Åse Mygland, MD, PhD study chair
Sorlandet Sykehus HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ceftriaxone and Doxycycline in people with Lyme Neuroborreliosis, run by Sorlandet Hospital HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00138801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.