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

Radboud University Nijmegen Medical Centre0 sites120 target enrollmentFebruary 10, 2011

Overview

No summary available.

Registry

who.int

Start Date

February 10, 2011

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Radboud University Nijmegen Medical Centre

•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

•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)