list a specific definition. Jos W.M. van der Meer is the chairman at
the department of internal medicine of the Radboud University Nijmegen
Medical Centre in Nijmegen, the Netherlands. Study Director Chantal P
Bleeker-Rovers, MD PhD is part of the faculty under Dr. van der Meer.
Dr. van der Meer has publicly documented his objections to the
International Consensus Criteria so it is unlikely that he will be
specifically studying patients with ME.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02468.x/full
"The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment"
study is currently recruiting participants.
Radboud University
Collaborator: ZonMw: The Netherlands Organisation for Health Research
and Development
ClinicalTrials.gov Identifier: NCT01318356
The objective of this study is to assess the efficacy of two treatment
strategies for fatigue and disabilities in QFS: long term treatment
with doxycycline (antibiotic) or cognitive behavioral therapy (CBT). Q
fever fatigue syndrome (QFS) is one of the most frequent sequelae of Q
fever, and constitutes a significant problem in the current outbreak
of Q fever. QFS leads to substantial morbidity and has a high
socio-economic burden, related to increased use of healthcare
facilities and absence from work. It is envisaged that over 750
patients will become chronically fatigued due to Q fever in The
Netherlands (20% of 4000 patients from 2007 until now). Although the
outbreak appears to diminish, it is expected that Q fever will remain
an endemic disease, and therefore this number will continue to grow. A
vast medical consumption can be anticipated, stressing the need for an
accessible and effective intervention and clear treatment guidelines.
The study will contribute to a better understanding of effective
treatment of QFS, providing evidence-based guidelines for general
practitioners and medical specialists.
Q Fever - Behavioral: Cognitive behavioral therapy - Phase IV - CBT
will consist of a protocolized intervention of 12 sessions during a
period of 24 weeks. It starts with goal setting and psycho-education
on the possible role of cognitions and behavior in maintaining the
fatigue. The maintaining factors will subsequently be addressed
(regulation of sleep-wake cycle, gradual increasing activity,
reformulating fatigue related cognitions).
Fatigue Syndrome, Chronic - Drug: Doxycycline - Antibiotic therapy
will consist of doxycycline once daily 200 mg (in 1 capsule) for 24
weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start
for side effects (rash, liver enzymes). Antibiotics will be stopped in
case of side effects or pregnancy.
Coxiella Infection Drug: Placebo - Patients in the placebo group will
receive once daily 1 placebo capsule identical in appearance to the
doxycycline for 24 weeks and have the same visits and monitoring for
side effects as the patients randomized to doxycycline (Patients will
be monitored 4, 8, 16 and 26 weeks)
Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Primary Outcome Measures:
Checklist Individual Strength (CIS) [ Time Frame: At baseline, after 8
weeks and after 24 weeks ] [ Designated as safety issue: No ]
The Checklist Individual Strength measures the fatigue severity. The
Checklist Individual Strength (CIS) (Vercoulen et. al, 1994)
quantifies subjective fatigue and related behavioral aspects. The CIS
consists of 20 statements for which the person has to indicate on a
7-point scale to what extent the particular statement applies to him
or her (1 =3D Yes, that is true; to 7 =3D No, that is not true). The
statements refer to four fatigue aspects: (1) subjective fatigue
(e.g., I feel tired), (2) reduced motivation (e.g., I feel no desire
to do anything), (3) reduced activity (e.g., I don't do much during
the day), and (4) reduced concentration (e.g., My thoughts easily
wander).
Secondary Outcome Measures:
Sickness Impact Profile (SIP) total score [ Time Frame: At baseline
and after 24 weeks ] [ Designated as safety issue: No ]
The Sickness Impact Profile measures the level of functional impairment
A 136-item self- or interviewer-administered, behaviorally-based,
health status questionnaire. Everyday activities in 12 categories
(sleep and rest, emotional behavior, body care and movement, home
management, mobility, social interaction, ambulation, alertness
behavior, communication, work, recreation and pastimes, and eating)
are measured. Respondents endorse items that describe themselves and
are related to their health. The SIP is scored according to the
number and type of items endorsed. Scoring can be done at the level
of categories and dimensions as well as at the total SIP level.
Symptom Checklist 90 (SCL90) [ Time Frame: At baseline and after 24
weeks ] [ Designated as safety issue: No ]
The total score of the Symptom Checklist 90 (SCL90) measures the level
of psychological distress. The SCL90 consists of 90 items scored on a
5-point scale. Scores range from 90 to 450. A low total score reflects
high psychological well-being. The SCL-90 is a reliable and valid
instrument.
The Symptom Checklist-90-Revised (SCL-90-R) is a 90-item self-report
symptom inventory developed by Leonard R. Derogatis in the mid-1970s
to measure psychological symptoms and psychological distress. It is
designed to be appropriate for use with individuals from the
community, as well as individuals with either medical or psychiatric
conditions. The SCL-90-R assesses psychological distress in terms of
nine primary symptom dimensions and three summary scores termed global
scores. The principal symptom dimensions are labeled Somatization
(SOM), Obsessive-Compulsive (OBS), Interpersonal Sensitivity (INT),
Depression (DEP), Anxiety (ANX), Hostility (HOS), Phobic Anxiety
(PHOB), Paranoid Ideation (PAR), and Psychoticism (PSY). The global
measures are referred to as the Global Severity Index (GSI), the
Positive Symptom Distress Index (PSDI), and the Positive Symptom Total
(PST). www.bli.uzh.ch/PDF/scl90E.pdf
Coxiella serology and PCR [ Time Frame: At baseline and after 26 weeks
] [ Designated as safety issue: No ]
Serology consists of the antibodies IgG and IgM fase I and II and
reflects the immunological respons to Coxiella burnetii of an
individual subject. This will be compared to the antibody
immunofluorescence titer measured at baseline.
Estimated Enrollment: 180
Study Start Date: April 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection
date for primary outcome measure)
Criteria
Inclusion Criteria:
Males or non-pregnant, non-lactating females who are 18 years or older
Laboratory-proven acute Q fever since the year 2007 and/or positive
serology fitting a past infection with Coxiella burnetii;
AND being severely fatigued, defined by scoring 35 or higher on the
subscale fatigue severity of the CIS;
AND being fatigued for at least 6 months;
AND disabled because of the fatigue, defined by scoring 450 or higher on th=
e SIP
Subjects must sign a written informed consent form.
Exclusion Criteria:
Fulfilling criteria for chronic Q fever, namely:
IFA IgG fase I =E2=89=A5 1024, =E2=89=A5 3 months after acute Q fever and/o=
r
Positive Coxiella burnetii PCR on serum or tissue, 1 month after acute Q fe=
ver
Acute Q fever in the setting of a prosthetic cardiac valve or aneurysm
surgery or stenting necessitating prophylactic use of doxycycline;
Pregnancy or unwillingness to use effective contraceptives during the
entire study period;
Imminent death;
Inability to give informed consent;
Allergy or intolerance to doxycycline;
Somatic or psychiatric illness that could explain the chronic fatigue;
Subjects who are currently enrolled on other investigational drug
trials or receiving investigational agents;
Receiving antibiotics for more than 4 weeks, potentially active
against Coxiella burnetii, for any other reason since Q-fever
diagnosis;
Subjects who are receiving and cannot discontinue barbiturates,
phenytoin, or carbamazepine (these drugs may increase the metabolism
of doxycycline and therefore reducing half-life of doxycycline);
Moderate or severe liver disease (AF, ALAT, ASAT > 3 times the upper
limit of normal).
Current engagement in a legal procedure concerning financial benefits
(only current involvement interferes with the effectivity of cognitive
behavioral therapy. Once the appeal procedure ends, subjects can be
included)
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