The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
Condition: Q Fever; Fatigue Syndrome, Chronic; Coxiella Infection
MeSH terms: Q Fever; Fatigue Syndrome, Chronic; Syndrome; Fatigue; Fever
Intervention: Cognitive behavioral therapy; Doxycycline; Placebo
Intervention description: 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.; 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)
Intervention MeSH terms: Doxycycline; Tetracycline
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Q fever; Cognitive behavioral therapy; Doxycycline; Fatigue; Coxiella

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).
    

Eligibility 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)