Fever of Unknown OriginNCT02618655
Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
An observational study of Fever of Unknown Origin and Tick-borne Diseases, run by Beijing Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fever of Unknown Origin, Tick-borne Diseases
- What is being tested?
- diagnostic methods
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Sep 2018
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all the people who have fever with unknown origin
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Organization Name Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, 100050
wenjie Qi, archiater, 13601318203, qwj02@126.com
About this study
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.
Read the 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.
- Conditions
- Fever of Unknown Origin, Tick-borne Diseases
- Being tested
- diagnostic methods
- Keywords
- TBDs；diagnosis
- Medical subject headings
- Fever of Unknown Origin, Tick-Borne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic methodsOther
explore several laboratory diagnostic methods to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.
| Study group | Role | What they receive |
|---|---|---|
| Fever，none definite diagnosis | Those who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available. Receives: Other: diagnostic methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood
Measured: within the first 14 days in hospital
Secondary outcomes (1)
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.
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fever of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Responsible party
- Principal investigator, Fu Xueying, Beijing Friendship Hospital
- Investigators
- wenjie Qi, archiater, Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618655
- Sponsor's protocol ID
- Z151100004015029
- Status last verified
- Jul 2016
- First submitted
- 28 Nov 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research for the Diagnosis of Tick-borne Diseases in Patients With Unexplained Acute Fever
- ClinicalTrials.gov ID
- NCT02618655
- Acronym / sponsor ID
- Z151100004015029
- Conditions
- Fever of Unknown Origin, Tick-borne Diseases
- Keywords
- TBDs；diagnosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Beijing Chao Yang Hospital
- Study start
- Mar 2015
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fever，none definite diagnosis | – | Other: diagnostic methodsThose who have fever，but the doctor can not make definite diagnoses with the diagnostic methods available. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all the people who have fever with unknown origin
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic methodsexplore several laboratory diagnostic methods to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs. | Other | Fever，none definite diagnosis |
Primary outcome
Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood
Time frame: within the first 14 days in hospital
1 secondary outcome
the sensitivity and specificity of the laboratory diagnostic methods Related to the reserach
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
wenjie Qi, archiater study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever of Unknown Origin and Tick-borne Diseases, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact wenjie Qi, archiater (010-63138749, qwj02@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of immunoglobulin M and immunoglobulin G titres in acute and convalescent serum or a fragment of the specific gene from patients' whole blood (time frame: within the first 14 days in hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.