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

Radboud University Nijmegen Medical Centre0 个研究点目标入组 120 人开始时间: 2011年2月10日最近更新: 2020年11月30日

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•Fulfilling criteria for chronic 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)

发起方

Radboud University Nijmegen Medical Centre