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.
Conditions
Interventions
Trade Name: Doxycycline Disp 100 PCH
Product Name: Doxycycline
Pharmaceutical Form: Capsule
CAS Number: 17086-28-1
Other descriptive name: DOXYCYCLINE MONOHYDRATE
Concentration unit: mg milligram(s)
C
Sponsors
Radboud University Nijmegen Medical Centre
Eligibility
Sex/Gender
All
Inclusion 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. 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT). Both interventions will be compared to a placebo group. Primary outcome measure will be fatigue severity measured with the Checklist Individual Strength (CIS).;Secondary Objective: Secondary outcome measures will be: •Level of functional impairment measured with the Sickness Impact Profile (SIP) total score; •Level of psychological distress measured with the total score of the Symptom Checklist 90 (SCL90). The SCL90 consists of 90 items scored on a 5-point scale. Scores range from 90 to 450. A low total score reflects high psychological well-being. The SCL-90 is a reliable and valid instrument •Coxiella serology and PCR (peripheral blood). ;Primary end point(s): Primary outcome measure will be fatigue severity measured with the CIS.;Timepoint(s) of evaluation of this end point: Primary outcome will be measured 24 weeks after start treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures will be: •Level of functional impairment measured with the SIP; •Level of psychological distress measured with the SCL90; •Coxiella serology and PCR. ;Timepoint(s) of evaluation of this end point: Level of functional impairment and the level of psychological distress will be measured 24 weeks after start treatment. Coxiella serology and PCR will be measured 26 weeks after start treatment. | — |
Countries
Netherlands
Contacts
Public ContactDepartment of Internal Medicine
Radboud University Nijmegen Medical Centre
Outcome results
None listed