CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 156 enrolled
Drug / intervention
Doxycycline +2 moredrug
Likely dose
Doxycycline 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01318356
NCT01318356Phase 4Completed
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The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment

Radboud University Medical Center·interventional·Posted Mar 18, 2011·Updated Jun 23, 2021

In Brief

A Phase 4 clinical trial evaluating Cognitive behavioral therapy, Doxycycline, and 1 other intervention for Q Fever and 2 related conditions. Completed, enrolled 156 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsQ Fever, Fatigue Syndrome, Chronic, Coxiella Infection
CountriesNetherlands
CollaboratorsZonMw: The Netherlands Organisation for Health Research and Development

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2011
Enrollment StartApr 1, 2011
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.3 years ago

Interventions

Cognitive behavioral therapybehavioral

CBT will consist of a protocolized intervention of 12 sessions during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).

Doxycyclinedrug

Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.

Placebodrug

Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)