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

Phase 1

• Conditions: Q fever fatigue syndrome (QFS) is one of the most frequent sequelae of Q fever. QFS leads to substantial morbidity, a high socio-economic burden and an increased use of healthcare facilities. QFS: • Complaints of severe fatigue defined as scoring 35 or higher on the subscale for fatigue severity (CIS)• Being fatigued for > 6 months• Being disabled because of fatigue (SIP score 450 or higher)• No somatic/psychiatric co-morbidity that could explain the chronic fatigue.; MedDRA version: 14.0Level: PTClassification code 10037688Term: Q feverSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.0Level: PTClassification code 10008874Term: Chronic fatigue syndromeSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-000643-25-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-10
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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.

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

Exclusion Criteria

•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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified