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:

Radboud University

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.

Condition	Intervention	Phase
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