Overview

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

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Treatments:
Doxycycline
Tetracycline
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)