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

Fever of Unknown Origin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02618655
• Other study ID #: Z151100004015029
• Status: Recruiting
• Phase: N/A
• First received: November 28, 2015
• Last updated: July 23, 2016
• Start date: March 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2016
• Source: Beijing Friendship Hospital
• Contact: wenjie Qi, archiater
• Phone: 010-63138749
• Email: qwj02[@]126.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fever
• Fever of Unknown Origin
• Tick-borne Diseases

Intervention

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

Locations

Country	Name	City	State
China	Organization Name Beijing Friendship Hospital,Capital Medical University	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No