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

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.

Study Overview

• Status: Unknown
• Conditions: Fever of Unknown Origin; Tick-borne Diseases
• Intervention / Treatment: Other: diagnostic methods

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: wenjie Qi, archiater; Phone Number: 010-63138749; Email: qwj02@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Organization Name Beijing Friendship Hospital,Capital Medical University
      • Contact: wenjie Qi, archiater; Phone Number: 13601318203; Email: qwj02@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all the people who have fever with unknown origin

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Collaborators: Beijing Chao Yang Hospital
• Investigators: Study Director: wenjie Qi, archiater, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: November 28, 2015
• First Submitted That Met QC Criteria: November 28, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Estimate): July 26, 2016
• Last Update Submitted That Met QC Criteria: July 23, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: TBDs；diagnosis
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Body Temperature Changes; Fever; Fever of Unknown Origin; Tick-Borne Diseases
• Other Study ID Numbers: Z151100004015029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES