The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Fatigue Syndrome, Chronic

Q Fever

Coxiella Infection

Treatments

Drug: Doxycycline

Behavioral: Cognitive behavioral therapy

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01318356

205520003-20110307

2011-000643-25 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)