The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Checklist Individual Strength (CIS)
研究概览
简要总结
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).
详细描述
Q fever fatigue syndrome (QFS) is one of the most frequent sequelae of Q fever, and constitutes a significant problem in the current outbreak of Q fever. QFS leads to substantial morbidity and has a high socio-economic burden, related to increased use of healthcare facilities and absence from work. It is envisaged that over 750 patients will become chronically fatigued due to Q fever in The Netherlands (20% of 4000 patients from 2007 until now). Although the outbreak appears to diminish, it is expected that Q fever will remain an endemic disease, and therefore this number will continue to grow. A vast medical consumption can be anticipated, stressing the need for an accessible and effective intervention and clear treatment guidelines.
The study will contribute to a better understanding of effective treatment of QFS, providing evidence-based guidelines for general practitioners and medical specialists.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Cognitive behavioral therapy
干预措施: Cognitive behavioral therapy (Behavioral)
Doxycycline
干预措施: Doxycycline (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Checklist Individual Strength (CIS)
时间窗: 24 weeks after start of treatment
The primary outcome measure is the fatigue severity measured by the subscale fatigue severity (8 items, 7-point Likert Scale) of the Checklist Individual Strength (CIS questionnaire) with a severity range from 8-56. High scores indicate a high level of fatigue. Patients with a cut-off score of ≥35 are classified as severely fatigued.
次要结局
- Sickness Impact Profile (SIP) Total Score(24 weeks after start of treatment)
- Symptom Checklist 90 (SCL90)(24 weeks after start of treatment)
研究者
Stephan Keijmel
S.P. Keijmel, MD
Radboud University Medical Center