In English: adult patients with Q fever Fatigue Syndrome. In Dutch: volwassenen met het Q-koortsvermoeidheidssyndroom
Conditions
Interventions
Allocation will be randomized:
1. CBT for 24 weeks (n=60)
2. Long-term antibiotic therapy using doxycycline 200 mg once daily for 24 weeks (n=60)
3. Placebo for 24 weeks (n=60)).
At first, randomization will occur between CBT or medication (ratio 1:2). If patients are randomized to the medication group, a second double-blinded randomization w
2. Doxycycline: Antibiotic therapy will consist of doxycycline once daily 200 mg (1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver en
3. Placebo: Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline capsules for 24 weeks and have the same visits and monitoring for side ef
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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; 3. Being severely fatigued, defined by scoring 35 or higher on the subscale fatigue severity of the CIS; 4. Being fatigued for at least 6 months; 5. Disabled because of the fatigue, defined by scoring 450 or higher on the SIP; 6. Subjects must sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Fulfilling criteria for chronic Q fever, namely: A. IFA IgG fase I ≥ 1024, ≥ 3 months after acute Q fever, and/or; B. Positive Coxiella burnetii PCR on serum or tissue, 1 month after acute Q fever. 2. Acute Q fever in the setting of a prosthetic cardiac valve or aneurysm surgery or stenting necessitating prophylactic use of doxycycline; 3. Pregnancy or unwillingness to use effective contraceptives during the entire study period; 4. Imminent death; 5. Inability to give informed consent; 6. Allergy or intolerance to doxycycline; 7. Somatic or psychiatric illness that could explain the chronic fatigue; 8. Subjects who are currently enrolled on other investigational drug trials or receiving investigational agents; 9. Receiving antibiotics for more than 4 weeks, potentially active against Coxiella burnetii, for any other reason since Q-fever diagnosis; 10. 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); 11. Moderate or severe liver disease (AF, ALAT, ASAT > 3 times the upper limit of normal); 12. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue severity measured with the Checklist Individual Strength (CIS). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Level of functional impairment measured with the Sickness Impact Profile (SIP) total score; 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; 3. Coxiella serology and PCR (peripheral blood). | — |
Contacts
Public ContactS.P. Keijmel
Radboud University Nijmegen Medical Centre Geert Grooteplein 8
Outcome results
None listed