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

• Conditions: Tick-borne Diseases; Fever of Unknown Origin
• Interventions: Other: diagnostic methods

• Registration Number: NCT02618655
• Lead Sponsor: Beijing Friendship Hospital

Brief 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.

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-11-28
• Study First Submitted QC: 2015-11-28
• Study First Posted: 2015-12-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-23
• Last Update Posted: 2016-07-26
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fever，none definite diagnosis	diagnostic methods	Those who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Organization Name Beijing Friendship Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China