Phase 4
Completed N=155
The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
Q Fever · Fatigue Syndrome, Chronic · Coxiella Infection
Source: ClinicalTrials.gov NCT01318356 ↗
Enrolled (actual)
155
Serious AEs
1.3%
Results posted
Jun 2021
Primary outcomePrimary: Checklist Individual Strength (CIS) — 31.6; 40.8; 37.8 score on a scale
◆ Published Evidence
Established
76citations · ~8 / year
Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial.
Summary
The objective of this study is to assess the efficacy of two treatment strategies for fatigue and disabilities in QFS: long term treatment with doxycycline or cognitive behavioral therapy (CBT).
Linked Publications (2)
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Effectiveness of Long-term Doxycycline Treatment and Cognitive-Behavioral Therapy on Fatigue Severity in Patients with Q Fever Fatigue Syndrome (Qure Study): A Randomized Controlled Trial.
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The Qure study: Q fever fatigue syndrome--response to treatment; a randomized placebo-controlled trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Checklist Individual Strength (CIS) |
31.6; 40.8; 37.8 | — |
| SECONDARY Sickness Impact Profile (SIP) Total Score |
786.8; 1101.5; 963.8 | — |
| SECONDARY Symptom Checklist 90 (SCL90) |
127.1; 149.2; 142.6 | — |
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)
Data sourced from ClinicalTrials.gov (NCT01318356) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.