Saturday, November 16, 2013

Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

This ongoing scientific study came to my attention today. It's being done in Holland, and the results should be known by spring, 2014. The sample size is pretty big -- 270 people. They are looking at the efficacy of intense IV therapy for Lyme (2000 mg of IV ceftriaxone 4 times a day). That's twice the dose I have done and most CLD (chronic Lyme disease)  patients I know have used. 

I'm pleased to see that the study recognizes ILADS as a legitimate medical entity with a set of treatment guidelines. It's also encouraging to see that this study is listed on the NIH (US National Institute of Health) web site. 

Estimated Enrollment:270
Study Start Date:September 2010
Estimated Study Completion Date:February 2014
Estimated Primary Completion Date:October 2013 (Final data collection date for primary outcome measure)
Estimated Enrollment:270
Study Start Date:September 2010
Estimated Study Completion Date:February 2014
Estimated Primary Completion Date:October 2013 (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/ct2/show/NCT01207739?term=borrelia&rank=14

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

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.


ConditionInterventionPhase
Lyme Disease
Borrelia Infection
Drug: Doxycycline
Drug: Clarithromycin and hydroxychloroquine
Drug: Placebo
Phase 4

Study Type:Interventional
Study Design:Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: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
http://clinicaltrials.gov/ct2/show/NCT01207739?term=borrelia&rank=14


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