the qure study: q-fever fatigue syndrome - response to treatment

Conditions: Q Fever; Fatigue Syndrome, Chronic; Coxiella Infection

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).

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.

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)

Keywords: q fever cognitive behavioral therapy doxycycline fatigue coxiella