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

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 180 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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.

•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).

发起方

niversitair Medisch Centrum Sint Radboud