Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT01318356
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01318356
Study Brief:
Protocol Section:
NCT01318356