The Qure study: Q-fever fatigue syndrome - response to treatment

Phase 4

Completed

Conditions: Coxiella burnetii
Q-fever
10004018

Registration Number: NL-OMON35884

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 180

Inclusion Criteria

1. Males or non-pregnant, non-lactating females who are 18 years or older
2. Laboratory-proven acute Q fever in the 3 years before presentation 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

1. Fulfilling criteria for chronic 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 burnetti, 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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure will be fatigue severity measured with the Checklist<br /><br>Individual Strength (CIS).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures will be:<br /><br>• Level of functional impairment measured with the Sickness Impact Profile<br /><br>(SIP) total score;<br /><br>• Level of psychological distress measured with the total score of the Symptom<br /><br>Checklist 90 (SCL90). The SCL90 consists of 90 items scored on a 5-point scale.<br /><br>Scores range from 90 to 450. A low total score reflects high psychological<br /><br>well-being. The SCL-90 is a reliable and valid instrument;<br /><br>• Coxiella serology and PCR (peripheral blood).</p><br>