The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
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).
Fatigue Syndrome, Chronic
Behavioral: Cognitive behavioral therapy
|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|
- 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
- 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.
|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)|
|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).
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.
|Placebo Comparator: 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318356
|Contact: Stephan P. Keijmel, MD||+31 24 3668256||Stephan.Keijmel@radboudumc.nl|
|Contact: Chantal P. Bleeker-Rovers, MD PhD||+31 24 3616319||Chantal.Bleeker-Rovers@radboudumc.nl|
|Radboud university medical center||Recruiting|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Contact: Stephan P. Keijmel, MD 0031243686256 Stephan.Keijmel@radboudumc.nl|
|Principal Investigator: Stephan P Keijmel, MD|
|Study Director:||Chantal P Bleeker-Rovers, MD PhD||Radboud University|