Reports on Meetings
LymeNet Newsletter
Volume: 2 Issue: 20 Date: 02-Dec-94
Table of Contents:
I. NIAID: Summary Of Second Consultation On Chronic LD
II. NIAID: Recent Projects at Rocky Mountain Labs
III. ANTIMICROB AGENTS CHEMOTHER: In vitro activity of
vancomycin against the spirochete Borrelia burgdorferi
IV. About The LymeNet Newsletter
Newsletter:
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* The National Lyme Disease Network *
* LymeNet Newsletter *
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IDX# Volume 2 - Number 20 - 12/02/94
IDX# INDEX
IDX#
IDX# I. NIAID: Summary Of Second Consultation On Chronic LD
IDX# II. NIAID: Recent Projects at Rocky Mountain Labs
IDX# III. ANTIMICROB AGENTS CHEMOTHER: In vitro activity of
IDX# vancomycin against the spirochete Borrelia burgdorferi
IDX# IV. About The LymeNet Newsletter
IDX#
I. NIAID: Summary Of Second Consultation On Chronic LD
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Sender: Edward McSweegan <EM8P@NIH.GOV>
On October 18, NIAID convened a second informal meeting on chronic
Lyme disease (LD). The discussion focused on possible clinical
trial designs for chronic LD, infectious and non-infectious aspects
of chronic LD, and potentially important co-infecting microorganisms
in some cases of chronic LD. The meeting also served to provide the
NIAID with a better understanding of the biomedical, logistical and
analytical issues involved in carrying out a treatment trial for
chronic LD. As noted at the first meeting on January 31, a
fundamental question about chronic LD is whether the lingering signs
and symptoms of post-treatment LD are due to persistent infection by
Borrelia burgdorferi or to non-infectious sequelae. Furthermore, if
persistent infection is common, is it antibiotic-responsive?
The answers to these questions are critical to guiding the care and
treatment of patients with evidence of chronic LD.
For purposes of the meeting, the term Post-Lyme Disease Syndrome
(PLDS) was used to describe a condition of chronic or intermittent
signs and symptoms coincident with the time of infection and
persisting for six months to years despite documentation of
appropriate antibiotic therapy. PLDS was further characterized by
symptoms of cognitive disturbances (encephalopathy), chronic fatigue
and malaise, headache, and joint and muscle pain. The PLDS concept
was useful for discussing chronic LD and for outlining various
etiologic considerations, including; persistent infection, incorrect
diagnosis, slow resolution of signs and symptoms, residual damage
from infection, re-infection, unmasking of a prior pathology, and a
post-infectious immune or inflammatory process.
Given the varied clinical presentations and possible etiologies
associated with PLDS, most of the meeting participants concluded
that an initial trial should focus on a well-defined patient
population with probable infection that might respond to antibiotics.
The use of an antibiotic-responsive or microbiologic case definition
in an antibiotic treatment trial would also simplify entry criteria,
endpoint and outcome measures, and reduce the necessary study size.
Entry criteria for such a treatment trial might include objective
measures such as positive serologies, a history of tick bite or EM
rash, compatible clinical signs and symptoms, repetitive positive
PCRs, positive culture, and severe fatigue (> 6 months) after
appropriate antibiotic therapy.
The use of a placebo was also thought by many participants to be
essential in measuring the efficacy of an antibiotic treatment.
The use of a double-blind, randomized, placebo-controlled trial
would allow investigators to determine if the antibiotic-treated
group improved significantly over the placebo group. Subsequent to
such a determination it would be possible to ask other questions
about optimal treatment duration, optimal drug route and optimal
drug choice.
The meeting participants noted, however, that it would be
unacceptable to enroll a placebo group into a treatment trial,
based on their likelihood of being infected, without eventually
treating them as aggressively as the antibiotic-treated group.
Various approaches, such as a cross-over and parallel track trial
designs, were discussed as ways of ensuring proper patient care
throughout the duration of a treatment study.
An initial well-designed treatment trial involving a select
population of PLDS patients would provide new information about
treating chronic LD and suggest additional avenues of patient care
and research. Most investigators recognized that in the absence of
a sufficient number of infected patients who had never been treated,
no particular group of LD patients would be uniform and ideal for a
given treatment trial. It was also noted that a patient group with
probable infection represented only the apex of a pyramid of PLDS
patients with varying clinical presentations and possible etiologies.
However, the intention of a first treatment trial would be to ask
treatment and diagnostic questions in one well-defined patient group
in the hope that the resulting answers could eventually be applied
to others.
A report of the October 18 meeting will be presented to the NIAID
Council at its next meeting in February 1995.
Chronic Lyme Disease: Clinical Trial Considerations
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Chairman - Steve Schutzer, M.D., Dept. of Medicine, UMDNJ. Med. Sch.
Janice I. Beers, J.D., L.D. Assoc. of the U.S.
William Blackwelder, Ph.D., Chief, Biometry, DMID/NIAID, NIH
Carl Brenner, L.D. Coalition of NY
Patricia Coyle, M.D., Dept. of Neurology, SUNY
George Curlin, M.D., Deputy Director, DMID/NIAID, NIH
Raymond Dattwyler, M.D., Div. Allergy, Rheum. & Clinical Immuno.
SUNY Sch. of Med.
Charlene DeMarco, M.D., Private Practice
David Dennis, M.D., Div. Vector-Borne Inf. Dis., CDC/NCID
Jesse Goodman, M.D., Div. of Medicine, U. of Minnesota
Stephen Heyse, M.D., Director, OPECA/NIAMS, NIH
Benjamin Luft, M.D., Div. of Inf. Dis., SUNY Sch. of Med.
Robin McKenzie, M.D., Lab. Clin. Invest., NIAID, NIH
David H. Persing, M.D., Lab. Med. Patho., Mayo Foundation
Robert Quackenbush, Ph.D., Chief, BMB/DMID/NIAID, NIH
Alfred J. Saah, M.D., School of Hygiene & Pub. Hlth, Johns Hopkins U.
Susana Serrate-Sztein, Ph.D., NIAMS, NIH
Janice M. Soreth, M.D., Div. Anti-Infective Drug Prod., NIH
Allen Steere, M.D., N.E. Med. Ctr., Rheumatology/Immunology
David L. Weld, Exec. Dir., American Lyme Disease Foundation Inc.
Edward McSweegan, Ph.D., NIAID
CONTACT: Edward McSweegan, Ph.D.
Lyme Disease Program Officer
National Institute of Allergy and Infectious Diseases
Solar Bldg., Rm. 3A34
Bethesda, MD 20892-7630
301-496-7728
301-402-2508 (fax)
EM8P@NIH.GOV
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