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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

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

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 Summary: 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.
Sponsor: Beijing Friendship Hospital

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

Original Primary Outcome: Evidence of IgM and IgG titres in acute and convalescent serum [ Time Frame: within the first 14 days in hospital ]

Current Secondary Outcome: the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach [ Time Frame: 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.


Original Secondary Outcome: targete a fragment of the specific gene from patients' whole blood by PCR [ Time Frame: within the first 14 days in hospital ]

Information By: Beijing Friendship Hospital

Dates:
Date Received: November 28, 2015
Date Started: March 2015
Date Completion: September 2018
Last Updated: July 23, 2016
Last Verified: July 2016