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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Fever of Unknown Origin, Tick-borne Diseases

Intervention / Treatment
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* Other: diagnostic methods


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fever，none definite diagnosis<br>Those who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available. | Other: diagnostic methods<br>* explore several laboratory diagnostic methods to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach | 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. | up to three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBDs；diagnosis