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)