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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02618655
Enrollment
200
Registered
2015-12-01
Start date
2015-03-31
Completion date
2018-09-30
Last updated
2016-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever of Unknown Origin, Tick-borne Diseases

Keywords

TBDs;diagnosis

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 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.

Interventions

OTHERdiagnostic 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.

Sponsors

Beijing Chao Yang Hospital
CollaboratorOTHER
Beijing Friendship Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frame
Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole bloodwithin the first 14 days in hospital

Secondary

MeasureTime frameDescription
the sensitivity and specificity of the laboratory diagnostic methods Related to the reserachup to three yearscompare 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.

Countries

China

Contacts

Primary Contactwenjie Qi, archiater
qwj02@126.com010-63138749

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026