Text Size

The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment

This study is currently recruiting participants.
Verified March 2013 by Radboud University
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Stephan Keijmel, Radboud University
ClinicalTrials.gov Identifier:
NCT01318356
First received: March 15, 2011
Last updated: March 14, 2013
Last verified: March 2013
History of Changes
  Purpose

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 or cognitive behavioral therapy (CBT).


Condition Intervention Phase
Q Fever
Fatigue Syndrome, Chronic
Coxiella Infection
 Behavioral: Cognitive behavioral therapy
Drug: Doxycycline
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Radboud University:

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


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

  • 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.

  • 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: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive behavioral therapy Behavioral: Cognitive behavioral therapy
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).
Other Names:
  • Behavior Therapy, Cognitive
  • Cognition Therapy
  • Cognitive Behavior Therapy
  • Cognitive Psychotherapy
  • Psychotherapy, Cognitive
  • Therapy, Cognition
  • Therapy, Cognitive
  • Therapy, Cognitive Behavior
Experimental: Doxycycline 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.
Other Names:
  • Doxycycline Monohydrate
  • Tetracycline
Placebo Comparator: Placebo 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)
Other Name: Sham Treatment

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 the SIP
  • Subjects must sign a written informed consent form.

Exclusion Criteria:

  • Fulfilling criteria for chronic Q fever, namely:

    • IFA IgG fase I ≥ 1024, ≥ 3 months after acute Q fever and/or
    • Positive Coxiella burnetii PCR on serum or tissue, 1 month after acute Q fever
  • 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318356

Contacts
Contact: Stephan P. Keijmel, MD +31 24 3668256 S.Keijmel@aig.umcn.nl
Contact: Chantal P. Bleeker-Rovers, MD PhD +31 24 3616319 C.Bleeker-Rovers@aig.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre Recruiting
Nijmegen, Gelderland, Netherlands, 6500 HB
Contact: Stephan P. Keijmel, MD     0031243686256     S.Keijmel@aig.umcn.nl    
Principal Investigator: Stephan P Keijmel, MD            
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Study Director: Chantal P Bleeker-Rovers, MD PhD Radboud University
  More Information

Additional Information:
Radboud University Nijmegen Medical Centre webpage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Stephan Keijmel, S.P. Keijmel, MD, Radboud University
ClinicalTrials.gov Identifier: NCT01318356     History of Changes
Other Study ID Numbers: 205520003-20110307, 2011-000643-25
Study First Received: March 15, 2011
Last Updated: March 14, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
Q fever
Cognitive behavioral therapy
Doxycycline
Fatigue
Coxiella

Additional relevant MeSH terms:
Fever
Q Fever
Fatigue
Fatigue Syndrome, Chronic
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
 Body Temperature Changes
Gram-Negative Bacterial Infections
Bacterial Infections
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 16, 2013