Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever

NCT02618655 — Unknown, 200 participants, Beijing Friendship Hospital

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Registry	NCT02618655
Status	Unknown
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Beijing Friendship Hospital (Other); collaborators: Beijing Chao Yang Hospital
Conditions	Fever of Unknown Origin, Tick-borne Diseases
Interventions	diagnostic methods (Other)
Dates	start 2015-03-01, primary completion 2018-09-01 (estimated), completion 2018-09-01 (estimated), first posted 2015-12-01, last updated 2016-07-26
Locations	1 site in China

-Summary

The study will use several laboratory diagnoses in the diagnosis of patients with fever，to find out which will be more helpful for making an accurate diagnosis in the early period of Tickborne Diseases.

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+Detailed description

Tickborne Diseases(TBDs) spread throughout many countries and regions. In recent years, the incidence has a tendency to rise continuously. The clinical symptoms and laboratory features of tick-borne diseases are always of no specific, and the diagnostic methods available, such as observing the pathogen after cultivation or by the method of Gimenez、serological tests for antibody always can't make a timely diagnosis, especially in the early period of the disease. The development of polymerase chain reaction(PCR) has been applied for pathogen detection, and showed high sensitivity and specificity,and may contribute to early diagnose，but no standardized method of PCR has been as yet proposed. This study mean to explore several laboratory diagnoses to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.

+Arms and interventions

Arm	Type	Interventions	Description
Fever，none definite diagnosis		Other: diagnostic methods	Those who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available.

diagnostic methods (Other): explore several laboratory diagnostic methods to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.

+Outcome measures

Primary outcomes

Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood [within the first 14 days in hospital]

Secondary outcomes

the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach [up to three years]: compare the sensitivity and specificity of all the laboratory diagnostic methods, using statistical methods, to find out the most helpful one for making an accurate diagnosis in the early period of TBDs.

+Eligibility

Sex: All

Inclusion Criteria:

* patients have fever more than one week
* temperature is higher than 38℃ Celsius degree
* full of physical examination and laboratory examination have been carried out after one week，but still cannot make a definite diagnosis

Exclusion Criteria:

* fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor
* we find that the patient selected does not meet the selection criteria within the observation period
* patients leave with automatic discharge

+Locations (1)

Facility	City	Country	Status
Organization Name Beijing Friendship Hospital,Capital Medical University	Beijing, Beijing Municipality	China	Recruiting

+Investigators

wenjie Qi, archiater, Study director, Beijing Friendship Hospital

My Notes

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