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

NCT02618655 | Unknown DMC

• 1 other identifier: Z151100004015029
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fever of Unknown Origin; Tick-borne Diseases

Keywords

TBDs；diagnosis

Outcome Measures

Primary Outcomes (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 Outcomes (1)

• the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach

  up to three years

Study Arms (1)

Fever，none definite diagnosis

Those who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available.

Other: diagnostic methods

Interventions

diagnostic methods OTHER

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

Fever，none definite diagnosis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all the people who have fever with unknown origin

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Beijing Chao Yang Hospital: collaborator

Study Sites (1)

Organization Name Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Fever of Unknown Origin; Tick-Borne Diseases

Condition Hierarchy (Ancestors)

Fever; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vector Borne Diseases; Infections

Study Officials

• wenjie Qi, archiater

  Beijing Friendship Hospital

  STUDY DIRECTOR

Central Study Contacts

wenjie Qi, archiater

CONTACT

010-63138749; qwj02@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever

Study Record Dates

• First Submitted: November 28, 2015
• First Posted: December 1, 2015
• Study Start: March 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 26, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)