Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University Medical Centre Ljubljana.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT00942006
First received: July 17, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 17, 2009
July 17, 2009
July 2009
November 2010   (final data collection date for primary outcome measure)
Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis
Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.

The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Suspected Early Lyme Neuroborreliosis
  • Drug: doxycycline
    100 mg bid, 14 days
  • Drug: ceftriaxone
    2g x 1 iv, 14 days
  • Active Comparator: LNB-doxycycline
    Intervention: Drug: doxycycline
  • Active Comparator: LNB-ceftriaxone
    Intervention: Drug: ceftriaxone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
November 2011
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age >15 years
  • erythema migrans in 4 months period before neurologic symptoms
  • normal CSF cell count
  • absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria:

  • pregnancy
  • lactation
  • allergy on doxycycline and ceftriaxone
  • immune deficiency.
Both
15 Years and older
No
Contact: Katarina Ogrinc, MD PhD +386 1 522 4217 katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, PhD MD +386 1 522 2110 franc.strle@kclj.si
Slovenia
 
NCT00942006
LNB-doxy-ceftriaxone
No
Katarina Ogrinc MD PhD, UMC Ljubljana
University Medical Centre Ljubljana
Not Provided
Study Chair: Franc Strle, MD PhD UMC Ljubljana
University Medical Centre Ljubljana
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP