drugset / Trial / NCT01318356
The Qure Study: Q-fever Fatigue Syndrome - Response to Treatment
Phase 4
Completed
156 enrolled
Radboud University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2011-04
- Primary completion
- 2015-09
- Completion
- 2015-09
Outcome
Missed primary endpoint
paper At EOT, fatigue severity was similar between doxycycline (40.8 [95% confidence interval {CI}, 37.3-44.3]) and placebo (37.8 [95% CI, 34.3-41.2]; difference, doxycycline vs placebo, -3.0 [97.5% CI, -8.7 to 2.6]; P = .45). PMID 28329131 ↗
paper Long-term treatment with doxycycline does not reduce fatigue severity in QFS patients compared to placebo. PMID 28329131 ↗
Publications
- Background Keijmel SP, Delsing CE, Sprong T, Bleijenberg G, van der Meer JW, Knoop H, Bleeker-Rovers CP. The Qure study: Q fever fatigue syndrome--response to treatment; a randomized placebo-controlled trial. BMC Infect Dis. 2013 Mar 27;13:157. doi: 10.1186/1471-2334-13-157.
- Keijmel SP, Delsing CE, Bleijenberg G, van der Meer JWM, Donders RT, Leclercq M, Kampschreur LM, van den Berg M, Sprong T, Nabuurs-Franssen MH, Knoop H, Bleeker-Rovers CP. 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. Clin Infect Dis. 2017 Apr 15;64(8):998-1005. doi: 10.1093/cid/cix013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxycycline | Small molecule | 200 mg | Oral |