Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01207739
First received: September 22, 2010
Last updated: July 12, 2013
Last verified: July 2013

September 22, 2010
July 12, 2013
September 2010
October 2013   (final data collection date for primary outcome measure)
Global score 36-item Short-form General Health Survey (SF 36) [ Time Frame: Week 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01207739 on ClinicalTrials.gov Archive Site
  • Subscales 36-item Short-form General Health Survey (SF 36) [ Time Frame: weeks 0, 14, 26 and 40 ] [ Designated as safety issue: No ]
  • Actometer recording during 14 days (objective physical activity) [ Time Frame: weeks 0, 14 and 40 ] [ Designated as safety issue: No ]
  • Measurements of neuropsychological impairment [ Time Frame: weeks 0, 14, 26 and 40 ] [ Designated as safety issue: No ]
  • Economic evaluation: Questionaire EQ-5D, health consumption and productivity of labour [ Time Frame: weeks 0, 14, 26 and 40 ] [ Designated as safety issue: No ]
  • Fatigue subscale of Checklist Individual Strength (CIS) [ Time Frame: weeks 0, 14, 26, and 40 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Persistent Lyme Empiric Antibiotic Study Europe
Persistent Lyme Empiric Antibiotic Study Europe. A Prospective, Randomised Study Comparing Two Prolonged Oral Antibiotic Strategies After Initial Intravenous Ceftriaxone Therapy for Patients With Symptoms of Proven or Possible Persistent Lyme Disease

The purpose of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with proven or presumed PLD (as endorsed by the international ILADS guidelines) leads to better patient outcome than short-term treatment as endorsed by the Dutch CBO guidelines.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Lyme Disease
  • Borrelia Infection
  • Drug: Doxycycline
    After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: oral Doxycycline 100 mg combined with a placebo b.i.d. for 12 weeks
    Other Names:
    • Doxycycline disper
    • CASnr 564-25-0 (doxycycline); 17086-28-1 (doxycycline monohydraat)
  • Drug: Clarithromycin and hydroxychloroquine
    After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: clarithromycin 500 mg combined with hydroxychloroquine 200 mg b.i.d. for 12 weeks
    Other Names:
    • Clarithromycine Mylan, RVG 32619
    • CASnr 81103-11-9
    • Hydroxychloroquine; Plaquenil, RVG 00853
    • CASnr 118-42-3 (hydroxychloroquine); 737-36-4 (hydroxychloroquine sulfate)
  • Drug: Placebo
    After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: 12 weeks' course of double placebo b.i.d.
  • Active Comparator: Doxycycline
    Intervention: Drug: Doxycycline
  • Active Comparator: Clarithromycin and hydroxychloroquine
    Intervention: Drug: Clarithromycin and hydroxychloroquine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
February 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males or non-pregnant, non-lactating females who are 18 years or older.
  • Women of child-bearing potential must agree to use contraception methods other than oral contraceptives during the study therapy period, since failure of oral contraceptives due to long-term antibiotic use has been described and doxycycline might be teratogenic.
  • Patients with presumed or proven PLD. In this study, clinical suspicion of PLD is defined as complaints of musculoskeletal pain, arthritis or arthralgia, neuralgia or sensory disturbances (such as paresthesias or dysesthesias), neuropsychological or cognitive disorders, and persistent fatigue, that are:

    • temporally related to an episode of erythema migrans or otherwise proven symptomatic Lyme disease (defined as within 4 months after erythema migrans as assessed by a physician, or positive biopsy, PCR, culture, intrathecal B. burgdorferi antibodies), OR
    • accompanied by a positive B. burgdorferi IgG or IgM immunoblot (as defined by strict criteria in line with the European Union Concerted Action on Lyme Borreliosis (EUCALB)), regardless of prior ELISA IgG/IgM screening results.
  • Subjects must sign a written informed consent form.

Exclusion Criteria:

  • Subjects with a known history of allergy or intolerance to tetracyclines, macrolides, hydroxychloroquine or ceftriaxone.
  • Subjects who have had more than 5 days of antimicrobial therapy with activity against B. burgdorferi within the previous 4 weeks.
  • Subjects with a presumed diagnosis of neuroborreliosis (CSF pleocytosis or intrathecal antibody production) for which intravenous antimicrobial therapy is required.
  • Subjects with a known diagnosis of HIV-seropositivity or other immune disorders. (No HIV serologic testing is required for the study).
  • Subjects with positive syphilis serology or signs of other spirochetal diseases.
  • Subjects with moderate or severe liver disease defined as alkaline phosphatase, ALAT, or ASAT greater than 3 times upper limit of normal.
  • Subjects who are receiving and cannot discontinue cisapride, astemizole, terfenadine, barbiturates, phenytoin, or carbamazepine (The concentrations of these drugs may increase during clarithromycin therapy and/or lead to reduced availability of doxycycline).
  • Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents.
  • Subjects who have been previously randomized into this study.
  • Severe physical or psychiatric co-morbidity that interferes with participation in the study protocol, including previous medical diagnosis of rheumatic conditions, chronic fatigue syndrome or chronic pain conditions as well as insufficient command of the Dutch language.
  • Co-morbidity that could (partially) account for the symptoms of the subject (e.g. vitamin B12 deficiency, anemia, hypothyroidism).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01207739
PLEASE, NL-27344.091.09, 2009-010939-40
Yes
Radboud University
Radboud University
  • Sint Maartenskliniek
  • ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Bart-Jan Kullberg, Prof., M.D. Radboud University
Radboud University
July 2013

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