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

Sponsor
Beijing Friendship Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02618655
Collaborator
Beijing Chao Yang Hospital (Other)
200
1
42.1
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
Study Start Date :
Mar 1, 2015
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Organization Name Beijing Friendship Hospital,Capital Medical University Beijing Beijing China 100050

Sponsors and Collaborators

  • Beijing Friendship Hospital
  • Beijing Chao Yang Hospital

Investigators

  • Study Director: wenjie Qi, archiater, Beijing Friendship Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fu Xueying, Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT02618655
Other Study ID Numbers:
  • Z151100004015029
First Posted:
Dec 1, 2015
Last Update Posted:
Jul 26, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Fu Xueying, Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever, Beijing Friendship Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2016