Re: Some Interesting Materials on the NIH Study
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Date: 01/10/05
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Date: 10 Jan 2005 07:11:41 -0800
PART 3
The "extramural" study:
-----------------------
NIH Chronic Lyme Disease Treatment Study Protocol
Sponsor: National Institutes of Health
National Institute of Allergy and
Infectious Diseases
Division of Microbiology and
Infectious Diseases
Clinical Studies in Chronic Lyme
Disease
Contract No. N01-AI-65308
Principal
Investigator: Mark S. Klempner, M.D.
Coordinating Center: New England Medical Center
Boston, Massachusetts
Clinical Centers: New York Medical College
Valhalla, New York
Yale University School of Medicine
New Haven, Connecticut
Protocols: A Phase III, randomized,
double-blind, placebo-controlled,
multicenter trial of the safety
and efficacy of ceftriaxone and
doxycycline in the treatment of
seropositive chronic Lyme disease.
A Phase III, randomized,
double-blind, placebo-controlled,
multicenter trial of the safety
and efficacy of ceftriaxone and
doxycycline in the treatment of
seronegative chronic Lyme disease.
Purpose of this Research Study
This research study is being conducted to determine if
treatment for a long period of time, with the antibiotic
drugs ceftriaxone and doxycycline, helps patients with
chronic Lyme disease. Lyme disease is caused by the bite
of an infected tick. Most people who get Lyme disease
are cured with standard antibiotic treatment. Some
people however, do not get well after standard
treatment. They have continuing (chronic) problems such
as pain in their joints or muscles, or problems with
their concentration or memory. For persons who have had
Lyme disease and have received the standard treatment
and have not gotten well, there is a possibility that
they have chronic Lyme disease. This study is designed
to see if giving more antibiotic will cure chronic Lyme
disease and to test for improvement of its symptoms.
Background Information
Lyme disease
Lyme disease is an infection which spreads throughout
the whole body. The disease begins when a type of
bacteria called Borrelia burgdorferi enters the skin
when a person is bitten by an infected tick. The
bacteria can spread through skin and blood to reach
parts of the body far from the tick bite. A very common
sign of early, active Lyme disease is a rash which grows
larger and larger in the rough shape of a circle. Other
symptoms of early disease can include fevers, muscle and
joint pains and joint swelling. Treatment with
antibiotics at the beginning of Lyme disease is very
effective at killing all of the bacteria and ending the
symptoms.
Unfortunately, some patients with Lyme disease who are
treated sometimes develop symptoms which don't go away.
These symptoms can include arthritis, nerve pains,
concentration and memory problems. Some people with
these continuing symptoms have gotten better when they
were given antibiotics and some have not. The ones who
do not get better are the patients referred to here as
chronic Lyme disease patients. At this point, it is not
clear whether those patients who have chronic Lyme
disease are helped by receiving higher doses, longer
treatment, or different antibiotics.
Description of this Research Study
This research study is being conducted under a contract
from the National Institute of Allergy and Infectious
Diseases which is part of the National Institutes of
Health. It will take place at three hospitals, New
England Medical Center in Boston, Massachusetts and New
York Medical College in Valhalla, New York, and Yale
University School of Medicine in New Haven, Connecticut.
Persons enrolled will be followed for one year. The
study will last for 5 years.
This is a randomized research study. This means that
half of the patients in this research study will be
given ceftriaxone and doxycycline antibiotics. The other
half of the patients will be given identical appearing
placebos, which are sterile solutions and pills that
appear identical to the antibiotics but contain no
active drug. Neither the patient nor their doctors will
know which one they receive. This is to prevent the
knowledge of which drug is being given from changing the
results of the study. There is a 50/50 chance that a
patient will get the ceftriaxone and doxycycline
antibiotics.
The study will measure the effects of giving 30 days of
I.V. (intravenous) ceftriaxone followed by 60 days of
oral doxycycline to patients with chronic Lyme disease.
A person may participate in this study only if they have
a positive blood test for Lyme disease or a skin rash
that is typical of early Lyme disease (erythema migrans)
documented by a physician in the past, have been
previously treated with antibiotics, and still have
continuing (chronic) symptoms. If enrolled, there will
be an initial evaluation at one of the study medical
centers. Treatment will then take place at home with
intravenous and oral study drugs. Half of the patients
enrolled will receive an intravenous dose (2 grams) of
ceftriaxone once per day. The other half of the patients
enrolled will receive an identical appearing sterile
solution, with no drug, once per day intravenously. At
the end of the 30 day intravenous therapy, the patients
who were receiving the ceftriaxone will receive 60 days
of doxycycline which will be taken in pill form
(100mg.), twice a day. Those who did not get the
ceftriaxone will take pills which are identical in
appearance to the doxycycline but contain no drug.
Patients will be assigned to each group randomly.
Neither the patient nor his/her physician will know
which group a patient is in.
In order to qualify for participation in this research
study, a blood test for Lyme disease must first be
performed. Results of this test take about 1 week to
determine. If test results meet the requirements for
participation in the study, patients will be asked to
return to the medical center for additional testing. At
that time, they will be given a complete physical
examination. A small amount of blood, (approximately 10
tablespoons) will be drawn. Additional blood samples
will be drawn at home on days 3, 5, 13, 21, 30, 45, and
75. Women of childbearing age will be given a urine test
for pregnancy. Urine samples for other testing (2
tablespoons) will be collected from all patients
initially, and at home on days 3, 5, 13, 21, 30, 45, and
75.
Patients with chronic Lyme disease may have infection of
the spinal fluid. A lumbar puncture (spinal tap) will be
performed on all patients who enter the study. This will
be done by a licensed, experienced physician. The lumbar
puncture will involve placing a small amount of local
anesthetic in the lower back and then placing a small
needle between the vertebrae (bones of the spine) and
withdrawing a small amount (about 3 tablespoons) of
spinal fluid. Patients who have abnormal spinal fluid
will have a second lumbar puncture at the completion of
the study.
Portions of all samples collected will be stored at New
England Medical Center for future research in chronic
Lyme disease only. Samples will be identified by code.
No personal identification will be included in sample
labeling.
Those with symptoms of numbness, tingling or nerve pain
will be tested to evaluate nerve function. This testing
will include Nerve Conduction Studies and
Electromyography. Nerve Conduction Studies are performed
first and take about 30-45 minutes. Patients will be
asked to lie down and small electrical connections will
be taped to several skin sites. A small electrical
signal is sent through the connection to the skin and
the response of the skin or the muscles beneath is
measured. These electrical signals feel like a small
shock andare almost alwayswell tolerated.
Electromyography is performed next and takes a total of
5-10 minutes. During this test, a small needle (smaller
than the needle used during blood drawing) is placed in
one or more muscles in the arm, leg or back. Electrical
activity in the muscle is measured when the muscle is at
rest and again when it is flexed. Placement of the
needles may be slightly painful, but no electrical
signals are delivered through the needles. The test
lasts 30-60 seconds per muscle. Information gained from
these two tests is then analyzed to determine if there
is evidence of nerve or muscle disease. Patients will be
tested again at 180 days.
Finally, Patients will be given a series of special
tests which are designed to measure whether there has
been any change in normal thinking abilities and how
their symptoms affect your their functioning. These
tests include measurements of concentration, memory,
language, and overall sense of physical and emotional
well being. These tests will take about 2 ½ hours to
complete. All of these tests will be repeated on day 90
to measure any change after treatment. A few will be
repeated on days 180 and 360.
Initial evaluations will require approximately 4 hours
at the medical center. Evaluations at 30 and 90 days
will require approximately 2 hours at the medical
center. Repeat testing at 180 days will require 2-6
hours depending on which symptoms of chronic Lyme
disease are being reassessed.
Evaluations of the initial test results must occur
before patients can be assigned to a group for this
study. After initial evaluation, they will go home. Once
the test results have been evaluated, they will be
contacted by study personnel and an appointment will be
made for them to return to the medical center. They will
have an intravenous catheter placed in a vein of their
arm. This involves washing the skin with disinfectant,
perhaps shaving some of the hair in a small area,
placing a small needle into a vein, threading a small
sterile plastic tube over the needle and withdrawing the
needle. The tube is then secured in place with adhesive
tape and flushed with sterile water. Patients will
receive their first dose of study drug under the
supervision of the investigator at the medical center.
At this point, they will be discharged to their home.
Before leaving, patients will be instructed in self
administration of pre-mixed intravenous study drug.
Intravenous study drug will be delivered to their home
twice during the initial 30 day period.
A Registered Nurse will visit patients in their home
every other day during the period of time that they are
receiving the intravenous study drug. The nurse will
measure vital signs, (blood pressure, heart rate,
breathing rate) draw any blood samples that are needed,
and check the intravenous catheter site. They will also
continue to instruct patients on any aspect of study
drug self administration.
Side Effects / Risks
Ceftriaxone
Ceftriaxone is an antibiotic that has been used widely
in the treatment of severe bacterial infections. It is
very effective in killing the Lyme disease bacteria in
the laboratory and it is effective in treating patients
with severe new Lyme disease infections. Ceftriaxone
will be given in I.V. (intravenous) form for one month.
The advantage of ceftriaxone over other antibiotics is
that it lasts in the bloodstream for a longer period of
time. This means it needs to be given only once a day.
Ceftriaxone is also better at penetrating into areas of
the body that are difficult to reach such as the central
nervous system or joints. Ceftriaxone has been shown to
be very safe given at these doses in a large number of
patients. The major side effects include rash (in about
1.7% of all cases), diarrhea (2.7%), changes in liver
function (approximately 3%) and gallstones (less than
1%). Liver function will be monitored during the study.
Ceftriaxone is related to penicillin and a small
percentage of patients with penicillin allergies will
have allergic reactions to ceftriaxone(5-8%). Patients
with allergies to penicillin should inform the
investigator prior to study entry. Although ceftriaxone
has not been documented to cause harm to a fetus or an
embryo, there have been no studies to document its
safety in pregnancy. Patients should inform the
investigator if they become pregnant at any point before
orduring theadministration ofceftriaxone.
Doxycycline
Doxycycline is an antibiotic that is commonly used in
the treatment of a wide range of infections including
Lyme Disease. Doxycycline will be given in oral (pill)
form, twice a day for two months, after finishing the
treatment with intravenous ceftriaxone. Doxycycline has
also been shown to be very safe in the dosages being
prescribed in this study. Reported side effects include
photosensitivity (exaggerated sunburn), rash,
gastrointestinal upset, changes in liver (rarely) and
kidney function. Doxycycline is known to harm unborn
babies and may cause birth defects. It should not be
taken during pregnancy. Patients should immediately
inform the investigator if they become pregnant at any
point before orduring the administration of
doxycycline.
Intravenous Catheterization
An intravenous catheter will be placed in a patient's
arm for the duration of the treatment with study drug
(30 days). There is a risk of infection with any
intravenous catheter and you must maintain it carefully
. Catheter infections are usually treated by removal of
the catheter, either with or without additional
antibiotics. Catheter infections which are left
untreated may progress to involve the skin surrounding
the catheter, the bloodstream and sites distant from the
catheter. Generalized infection resulting from untreated
catheter infections can be fatal. Patients must inform
the investigator immediately if there are any signs of
infection of the catheter (redness, pus, tenderness).
The catheter site will be monitored closely by the
investigators and the study nurses.
Lumbar Puncture
The lumbar puncture is a safe procedure in healthy
patients as well as in patients with Lyme disease. The
most common side effect following a lumbar puncture,
occurring in approximately 2-10% of patients undergoing
this procedure, is a headache which may persist from 1
to 5 days (considerably longer in rare instances). The
leakage of spinal fluid is suspected of causing post-LP
headaches. The risk of headache can be reduced by lying
flat in bed for 24 hours following the procedure. In the
case of a prolonged post-LP headache--i.e. a headache
that lasts more than 2-3 days-- treatment with a blood
patch may be employed. This treatment involves the
withdrawing of a small amount of blood from a vein which
is then injected at the site of the lumbar puncture to
provide a seal and prevent further leakage of spinal
fluid. There is also a small chance of having an
allergic reaction to the local anesthetic. If you have
had prior reactions to anesthetics, you must inform the
investigator. Lastly, there is a small chance of
developinginfection followinglumbar puncture.
Blood Drawing
Blood will be drawn at various times during the study.
This procedure involves a small amount of discomfort as
a needle is placed in a vein and blood is withdrawn into
test tubes. There is a small risk of infection as well
as a small possibility of bruising around the site.
Pregnancy
For women, a pregnancy test will be performed which must
be negative before enrollment in the study. If a woman
becomes pregnant at any time during, or for 1 month
after the period of drug administration, the study drugs
used in this research study may cause harm to her unborn
baby or cause birth defects. The use of doxycycline (a
tetracycline), one of the two antibiotics patients may
receive by participating in this study, is known to
cause discoloration (yellow-gray) of the teeth in
children if their mother took the drug during the last
half of pregnancy. In addition, there is evidence of
toxic effects to embryos when tetracyclines have been
administered to pregnant animals. Therefore, it is
important that women are not pregnant nor plan to become
pregnant during the course of the study. If a woman
chooses to participate, she must use adequate birth
control (e.g. barrier method, oral or implant
contraceptive or abstinence) to prevent pregnancy during
this study. Should a female patient become pregnant at
any time during this study, she must immediately notify
her physician and study personnel. She will be
discontinued from the study and she will be followed by
study personnel.
Benefits
We do not know if ceftriaxone and doxycycline will be
effective against chronic Lyme disease. Patients in both
groups will receive all of the testing necessary to
evaluate the disease and its progress.
Participation in this study will afford patients the
possibility of treatment which may be effective in
resolving the symptoms of chronic Lyme disease. If at
any time a patient's condition changes so that the
participation in this study is no longer in their best
interest, the treatment will be stopped and a new plan
will be discussed. If a more effective treatment becomes
available, doctors will discuss this new alternative
with patients. If, at the completion of the study, the
protocol treatment is found to be effective, and a
patient has received the placebo, they will be offered
the study treatment regimen (30 days of intravenous
Rocephin, 2 grams per day, followed by 60 days of oral
doxycycline, 200mg per day) through their regular health
care insurance coverage. If coverage for treatment is
denied by regular health care insurance, or if a patient
does not have health insurance, the costs of such
treatment will be paid through the contract supporting
these studies.
Alternatives
A person may choose not to participate in this
particular study. Various other treatment options are
available through personal physicians; however, there
are currently no proven effective treatments for chronic
Lyme disease. If a person chooses not to participate in
this research study, their decision will not affect any
future care they may receive at these institutions.
Confidentiality
Representatives of the United States Food and Drug
Administration (FDA), the National Institutes of Health
(NIH, sponsor of the study), and the manufacturers of
the drugs may inspect patient records. Information
gained from the study will be reported to the NIH, FDA,
and perhaps other regulatory authorities. When results
of a study such as this are reported in the medical
journals or at meetings, identification of those taking
part is withheld. Medical records of patients are
maintained in confidence according to current legal
requirements. They are made available for review to
authorized users only under the guidelines established
by the Federal Privacy Act.
Patient Costs
Costs directly relating to the study (blood tests,
antibiotics,intravenouscatheterization,lumbar
puncture, EMG) will be covered by the study.
More Information
For more information, please call the Chronic Lyme
Disease Study toll free phone line at 888-596-3287 and
leave your name and phone number and you will be
contacted by study personnel or call Mr. Gary Johnson,
Clinical Trials Manager at 617-636-4893.
NIH Chronic Lyme Disease Treatment Study Protocol
http://www.niaid.nih.gov/dmid/lymeprotocol.htm
-----
Seropositive Chronic Lyme Disease
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter
Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the
Treatment of Seropositive Chronic Lyme Disease
Principal Investigator: Mark S. Klempner, M.D.
Co-Investigators: Arthur Weinstein, M.D., Linden Hu, M.D., Allen C.
Steere, M.D., and Gary Wormser, M.D.
Participating Centers: The New England Medical Center, Boston, MA,
and the New York Medical College, Valhalla, NY.
Description of the Study: Lyme disease (LD) is the most common
tick-borne infection in the United States. It is caused by Borrelia
burgdorferi, a spirochete, that is transmitted to humans and other
animals by Ixodes ticks. The natural reservoir for this infectious
agent
is rodents; however, other types of mammals and some birds also may
become infected.
As with many infectious diseases, the clinical signs of LD are variable
and unpredictable. Early manifestations include a rash (erythema
migrans), general malaise, and flu-like symptoms. Chronic
manifestations
include arthritis, as well as cardiac and neurologic manifestations
that
have been reported to remit spontaneously and recur even after
antibiotic therapy.
Recently, the term Chronic Lyme Disease (CLD) has been used to
describe a condition of chronic or intermittent symptoms related to LD.
The cause of CLD is not known, but several possibilities have been
suggested. The first is that it is a manifestation of a chronic active
infection by B. burgdorferi that has escaped control or eradication by
conventional antibiotic therapy. A second possibility is that CLD may
be
due to damage caused by the original infectious process, including the
triggering of post-infectious immune phenomena, despite eradication of
the spirochete. A third possibility is the presence of a co-infection
with other microorganisms also transmitted by infected Ixodes ticks.
Objectives: The objectives of this study are to determine whether: [a]
intensive antibiotic treatment benefits seropositive patients with CLD;
[b] evidence of persistent infection with B. burgdorferi can be found
in
patients with CLD; [c] evidence of co-infection with other
microorganisms can be found in patients with CLD; [d] specific clinical
or laboratory parameters improve in patients receiving antibiotic
therapy in contrast to patients given placebo; and, [e] specific
parameters are predictive of a beneficial response, should it be
observed.
Design of the Study: Since this is to be a double-blind study, neither
the patients nor their doctors (study personnel) will know whether they
are receiving antibiotic or placebo. Patients enrolled in the study
will
be randomized (in a 1:1 ratio) to receive either antibiotic or placebo,
which will be administered both intravenously and orally. Separate
randomization schedules will be generated for each of the two study
centers by the NIAID or its designate. Thus, only the NIAID or its
designate will know who is receiving antibiotic or placebo; this will
not be revealed to the study personnel or patients until the study has
been completed and the results are ready to be analyzed. The study
population will include a defined cohort of patients with CLD, who are
seropositive for Lyme disease (by the two-test CDC-Dearborn criteria)
at
the time of enrollment, and who meet the inclusion and exclusion
criteria established for this study.
The antibiotic regimen will be ceftriaxone, 2.0 grams per day,
administered once daily by the intravenous route for 30 consecutive
days, followed by doxycycline, 100 milligrams given every 12 hours, by
the oral route for 60 consecutive days. Placebos identical in
appearance
to the intravenous and oral antibiotics will be administered by the
same
routes, and for the same duration of time, to patients randomized to
the
placebo group.
Primary analysis of the efficacy of the antibiotic therapy to be tested
in this study will be determined by improvement in the patient’s
health-
related quality of life, as measured by the SF-36 Health Survey; it
includes eight multi-item scales that measure physical functioning,
role-physical, bodily pain, general health, vitality, social
functioning, role-emotional, and mental health.
Three additional multi-item scales from the medical outcomes study
(MOS)
will be used to measure cognitive functioning, pain, and role
functioning, but they will not be used for primary analysis of efficacy
of antibiotic therapy. The SF-36 Health Survey (and additional MOS
measures) will be administered to study participants four times: at
baseline (prior to therapy), at one month (end of intravenous
treatment), at three months (end of intravenous and oral treatment),
and
at six months. Also, at baseline and at defined intervals during the
course of these studies, specimens will be collected to test for (a) an
immune response to B. burgdorferi antigens in serum and cerebrospinal
fluid (CSF); (b) B. burgdorferi DNA in CSF; (c) viable B. burgdorferi
in
CSF; (d) B. burgdorferi antigens in urine; and, serum antibodies
specific for possible co-infecting agents, e.g., Babesia microti.
Questions: Any questions concerning participation in this study should
be addressed to either Dr. Mark Klempner or Dr. Linden Hu at 1-888-LYME
CTR (1-888-596-3287).
For additional information, click here to go to the Chronic Lyme
Treatment Study Web site maintained by the New York Medical College.
Seropositive Chronic Lyme Disease
http://www.niaid.nih.gov/recruit/phsiiip.htm
-----
Seronegative Chronic Lyme Disease
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter
Trial of the Safety and Efficacy of Ceftriaxone and Doxycycline in the
Treatment of Seronegative Chronic Lyme Disease
Principal Investigator: Mark S. Klempner, M.D.
Co-Investigators: Arthur Weinstein, M.D., Linden Hu, M.D., Allen C.
Steere, M.D., and Gary Wormser, M.D.
Participating Centers: The New England Medical Center, Boston, MA,
and the New York Medical College, Valhalla, NY.
Description of the Study: Lyme disease (LD) is the most common
tick-borne infection in the United States. It is caused by Borrelia
burgdorferi, a spirochete, that is transmitted to humans and other
animals by Ixodes ticks. The natural reservoir for this infectious
agent
is rodents; however, other types of mammals and some birds also may
become infected.
As with many infectious diseases, the clinical signs of LD are variable
and unpredictable. Early manifestations include a rash (erythema
migrans), general malaise, and flu-like symptoms. Chronic
manifestations
include arthritis, as well as cardiac and neurologic manifestations
that
have been reported to remit spontaneously and recur even after
antibiotic therapy.
Recently, the term Chronic Lyme Disease (CLD) has been used to
describe a condition of chronic or intermittent symptoms related to LD.
The cause of CLD is not known, but several possibilities have been
suggested. The first is that it is a manifestation of a chronic active
infection by B. burgdorferi that has escaped control or eradication by
conventional antibiotic therapy. A second possibility is that CLD may
be
due to damage caused by the original infectious process, including the
triggering of post-infectious immune phenomena, despite eradication of
the spirochete. A third possibility is the presence of a co-infection
with other microorganisms also transmitted by infected Ixodes ticks.
Objectives: The objectives of this study are to determine whether: [a]
intensive antibiotic treatment benefits seronegative patients with CLD;
[b] evidence of persistent infection with B. burgdorferi can be found
in
patients with CLD; [c] evidence of co-infection with other
microorganisms can be found in patients with CLD; [d] specific clinical
or laboratory parameters improve in patients receiving antibiotic
therapy in contrast to patients given placebo; and, [e] specific
parameters are predictive of a beneficial response, should it be
observed.
Design of the Study: Since this is to be a double-blind study, neither
the patients nor their doctors (study personnel) will know whether they
are receiving antibiotic or placebo. Patients enrolled in the study
will
be randomized (in a 1:1 ratio) to receive either antibiotic or placebo,
which will be administered both intravenously and orally. Separate
randomization schedules will be generated for each of the two study
centers by the NIAID or its designate. Thus, only the NIAID or its
designate will know who is receiving antibiotic or placebo; this will
not be revealed to the study personnel or patients until the study has
been completed and the results are ready to be analyzed. The study
population will include a defined cohort of patients with CLD, who are
seronegative for Lyme disease (by the two-test CDC-Dearborn criteria)
at
the time of enrollment, and who meet the inclusion and exclusion
criteria established for this study.
The antibiotic regimen will be ceftriaxone, 2.0 grams per day,
administered once daily by the intravenous route for 30 consecutive
days, followed by doxycycline, 100 milligrams given every 12 hours, by
the oral route for 60 consecutive days. Placebos identical in
appearance
to the intravenous and oral antibiotics will be administered by the
same
routes, and for the same duration of time, to patients randomized to
the
placebo group.
Primary analysis of the efficacy of the antibiotic therapy to be tested
in this study will be determined by improvement in the patient’s
health-
related quality of life, as measured by the SF-36 Health Survey; it
includes eight multi-item scales that measure physical functioning,
role-physical, bodily pain, general health, vitality, social
functioning, role-emotional, and mental health.
Three additional multi-item scales from the medical outcomes study
(MOS)
will be used to measure cognitive functioning, pain, and role
functioning, but they will not be used for primary analysis of efficacy
of antibiotic therapy. The SF-36 Health Survey (and additional MOS
measures) will be administered to study participants four times: at
baseline (prior to therapy), at one month (end of intravenous
treatment), at three months (end of intravenous and oral treatment),
and
at six months. Also, at baseline and at defined intervals during the
course of these studies, specimens will be collected to test for (a) an
immune response to B. burgdorferi antigens in serum and cerebrospinal
fluid (CSF); (b) B. burgdorferi DNA in CSF; (c) viable B. burgdorferi
in
CSF; (d) B. burgdorferi antigens in urine; and, serum antibodies
specific for possible co-infecting agents, e.g., Babesia microti.
Questions: Any questions concerning participation in this study should
be addressed to either Dr. Mark Klempner or Dr. Linden Hu at 1-888-LYME
CTR (1-888-596-3287).
For additional information, click here to go to the Chronic Lyme
Treatment Study Web site maintained by the New York Medical College.
Seronegative Chronic Lyme Disease
http://www.niaid.nih.gov/recruit/phsiiin.htm
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