Clinical Trial: The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: Radboud University
Current Primary Outcome: Checklist Individual Strength (CIS) [ Time Frame: At baseline, after 8 weeks and after 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Sickness Impact Profile (SIP) total score [ Time Frame: At baseline and after 24 weeks ]The Sickness Impact Profile measures the level of functional impairment
- Symptom Checklist 90 (SCL90) [ Time Frame: At baseline and after 24 weeks ]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 ]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.
Original Secondary Outcome: Same as current
Information By: Radboud University
Dates:
Date Received: March 15, 2011
Date Started: April 2011
Date Completion:
Last Updated: October 12, 2015
Last Verified: October 2015