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Table 2 Exclusion criteria

From: The Qure study: Q fever fatigue syndrome – response to treatment; a randomized placebo-controlled trial

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 in other investigational drug trials or receiving investigational agents

(9)

Receiving or having received antibiotics for > 4 weeks, potentially active against Coxiella burnetii, for any other reason since Q fever diagnosis

(10)

Subjects who are receiving and cannot discontinue barbiturates, phenytoin, or carbamazepine**

(11)

Moderate or severe liver disease (AF, ALT, AST > 3 times the upper limit of normal)

(12)

Current engagement in a legal procedure concerning financial benefits#

  1. * According to the guideline chronic Q fever from the Dutch Q fever consensus group[29].
  2. ** These drugs may increase the metabolism of doxycycline; consequently, reducing the half-life of doxycycline.
  3. # Temporary exclusion criterion, while current involvement interferes with the effectivity of cognitive behavioral therapy [30]. Once the appeal procedure ends, subjects can be included.
  4. Abbreviations: AF = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase.