NL-OMON35884
Completed
Phase 4
The Qure study: Q-fever fatigue syndrome - response to treatment - The Qure study
niversitair Medisch Centrum Sint Radboud0 sites180 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coxiella burnetii
- Sponsor
- niversitair Medisch Centrum Sint Radboud
- Enrollment
- 180
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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);
Outcomes
Primary Outcomes
Not specified
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