The Qure study: Q-fever fatigue syndrome - response to treatment.
- Conditions
- In English: adult patients with Q fever Fatigue Syndrome. In Dutch: volwassenen met het Q-koortsvermoeidheidssyndroom
- Registration Number
- NL-OMON25227
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Stephan P. Keijmel, Corine E. Delsing, Gijs Bleijenberg, Jos W. M. van der Meer, Rogier T. Donders, Monique Leclercq, Linda M. Kampschreur, Michel van den Berg, Tom Sprong, Marrigje H. Nabuurs-Franssen, Hans Knoop, Chantal P. Bleeker-Rovers; Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial. Clin Infect Dis 2017 cix013. doi: 10.1093/cid/cix013
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
1. Males or non-pregnant, non-lactating females who are 18 years or older;
2. Laboratory-proven acute Q fever since the year 2007 and/or positive serology fitting a past infection with Coxiella burnetii;
1. Fulfilling criteria for chronic Q fever, namely:
A. IFA IgG fase I ≥ 1024, ≥ 3 months after acute Q fever, and/or;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fatigue severity measured with the Checklist Individual Strength (CIS).
- Secondary Outcome Measures
Name Time Method 1. Level of functional impairment measured with the Sickness Impact Profile (SIP) total score;<br /><br>2. Level of psychological distress measured with the total score of the Symptom Checklist 90 (SCL90). 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;<br /><br>3. Coxiella serology and PCR (peripheral blood).