Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

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rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by rlstanley » Wed 30 Mar 2011 16:57

http://clinicaltrials.gov/ct2/show/NCT01207739

Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)


This study is currently recruiting participants.


Sponsor: Radboud University
Collaborators: Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development

Information provided by: Radboud University
ClinicalTrials.gov Identifier: NCT01207739

Purpose
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.
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
Estimated Enrollment: 270
Study Start Date: September 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Details at: http://clinicaltrials.gov/ct2/show/NCT01207739

rlstanley
Posts: 1637
Joined: Mon 3 Dec 2007 2:53

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by rlstanley » Thu 31 Mar 2011 2:13

http://www.trialregister.nl/trialreg/ad ... sp?TC=2469
hypothese (hypothesis)

Prolonged antibiotic treatment of patients diagnosed with 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.
Brief summary

This study is a double blind, randomised, placebo-controlled trial of prolonged antibiotic treatment after intravenous ceftriaxone. All patients will initially receive open-label i.v. ceftriaxone in a home-care setting for two weeks, which is the standard of care for presumed or proven neuroborreliosis according to both guidelines. Then patients will be randomised to one of 3 treatment arms. Subsequently, blinded oral follow-on treatment will be given in 3 randomisation arms:

1. Oral doxycycline for 12 weeks;
2. Oral clarithromycin plus hydroxychloroquine for 12 weeks, or;
3. Oral placebo for 12 weeks.

The primary goal of the study is to establish whether prolonged antibiotic treatment of patients diagnosed with 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. Secondary objectives will be studied in an explorative way. The secondary goals include the effect of randomised treatment modalities on pain, functional impairment, psychological functioning, social behaviour, cognitive functioning, and safety. Moreover, cost-effectiveness will be determined by assessment of costs from societal perspective and quality-adjusted life years.

Screening will be done according standard clinical and laboratory protocols. After obtaining informed consent, baseline assessments include clinical, laboratory, microbiological and (neuro)psychological evaluation and objective assessment of physical activity, using an accelerometer.

Study visits will be performed at baseline, week 2, 8 and 14 for safety evaluation. Efficacy evaluation will be performed at week 14 (end of treatment period, EOT), and at week 26 (12 weeks after EOT) and week 40 (end of study, EOS, 26 weeks after EOT), consisting of clinical and psychological assessment and accelerometer registration.

peter_j
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Joined: Sun 29 Jul 2007 0:15

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by peter_j » Thu 6 Mar 2014 10:18

Hello

Is here anyone who knows anything about when this study will be published, or who speak Dutch and can ask the scientists?

http://clinicaltrials.gov/show/NCT01207739

Margherita
Posts: 192
Joined: Thu 27 Sep 2012 18:22

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Margherita » Thu 6 Mar 2014 20:47

Hi Peter,

Pls. contact the webmoderator of this forum. Most probably he can help you.

Martian
Posts: 1944
Joined: Thu 26 Jul 2007 18:29
Location: Friesland, the Netherlands

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Martian » Thu 6 Mar 2014 21:45

peter_j wrote:Hello

Is here anyone who knows anything about when this study will be published, or who speak Dutch and can ask the scientists?

http://clinicaltrials.gov/show/NCT01207739
If you follow that link you can find this data:
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)
I don't know how long such normally takes, but if the study was completed in February 2014, it may be published later this year or next year I think.

This is a Dutch website about the study: http://www.lymeonderzoek.nl/

It says on that site that for questions about the scientific research you can send and e-mail to: info < at > lymeonderzoek.nl. I'm sure they command English language.

peter_j
Posts: 8
Joined: Sun 29 Jul 2007 0:15

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by peter_j » Thu 6 Mar 2014 22:17

Thanks a lot for the link, Martian. Do you know if there's a lot of buzz around it in the Netherlands? This is the only ongoing study I know of that has the potential to bring about a change in how the «establishment» looks at the disease.

lou
Posts: 215
Joined: Fri 2 Nov 2007 0:41

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by lou » Fri 7 Mar 2014 2:27

This is very much like the Klempner trials of a decade ago, which used the same time period with people who had been sick a long time. And most of them as I recall had already had treatment of this length. It was set up to fail, and it did fail. The conclusion was drawn from this that more treatment did not help.

So, it is unlikely that this will help any lyme patients, sorry to say. It is certainly not a good test of whether ILADS guidelines are any more successful.

In fact, this looks like a very cynical ploy to me. I feel very sorry for the Dutch patients who pinned any hope on the trial.

Lorima
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Joined: Mon 29 Oct 2007 20:47

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Lorima » Fri 7 Mar 2014 2:43

I was wondering, too, about why they would bother to essentially repeat the old study format. We already know that 3 months of treatment won't reliably give long-term health gains to people with late dissseminated LD, so why bother to do this again, with the small tweak of using clari instead of doxy in some patients?
"I have to understand the world, you see."
Richard Feynman

peter_j
Posts: 8
Joined: Sun 29 Jul 2007 0:15

Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by peter_j » Fri 7 Mar 2014 16:44

Does anyone know where the scientists stand in the debate about chronic lyme? I am not aware of a single patient with chronic disease who is in remission following long term ceftriaxone, but I know many whom benefit greatly from a couple of months with clarithromycin and hydroxychloroquine, although the improvements seldom last when they are taken off the drugs.

Camp Other
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Re: Persistent Lyme Empiric Antibiotic Study Europe (PLEASE)

Post by Camp Other » Fri 7 Mar 2014 17:12

Lorima wrote:I was wondering, too, about why they would bother to essentially repeat the old study format. We already know that 3 months of treatment won't reliably give long-term health gains to people with late dissseminated LD, so why bother to do this again, with the small tweak of using clari instead of doxy in some patients?
It was my understanding that what was more important was that the study used a combination of clarithromycin plus hydroxychloroquine - combination therapy rather than monotherapy. Also, I believe to some degree the protocol design was based on Dr. Sam Donta's treatment approach.

I'm not saying 3 months treatment is going to be optimal - it may help some people depending on how long they've been infected and if their case isn't too complicated (coinfections, immune factors, comorbidities, etc). But it is a good thing that it is at least testing combination therapy.

Duration is an entirely different story. No one has determined optimal duration for those who have early treatment failure or who are treated late. Outcomes vary.

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