Objectives* The primary aim is to study the kinetics of QFT-G in military personnel with a positive TST result. * Secondary aims are to study the practical feasibility of using QFT-G in the setting of a military hospital.Next to this we wish to…
ID
Source
Brief title
Condition
- Mycobacterial infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
sequential results of QFT-G test
Secondary outcome
0
Background summary
Short title
Evaluation of the kinetics of the Quantiferon TB Gold whole blood assay
measuring M. tuberculosis-specific immune responses in military personnel with
a positive tuberculin skin test.
Background
The detection and treatment of latent tuberculosis (TB) infection in military
personnel has thus far been based on the tuberculin skin test (TST). Once the
TST has been found to be positive, it remains positive and can no longer be
used for the detection of reinfection. In a previous study, Quantiferon TB Gold
(QFT-G), a whole blood assay specific for MTB infection was evaluated in 900
subjects. Results showed that positive QFT-G results were found in only a
minority of individuals with a positive TST. This could be due either to
false-positive TST results due to exposure to environmental mycobacteria or due
to conversion from QFT-G positive to negative, either spontaneously or during
treatment.
Study objective
Objectives
* The primary aim is to study the kinetics of QFT-G in military personnel with
a positive TST result.
* Secondary aims are to study the practical feasibility of using QFT-G in the
setting of a military hospital.
Next to this we wish to confirm/ investigate the reproducibility of the result
of previous study. IF so ,then there will be an urgent need to revisit the
current approach /guidelines of treatment of latent tuberculosis.
Study design
Design
All military personnel who are treated for a recently detected positive TST
result will undergo serial QFT-G at 0, 2, 6 and 12 months. Those who decline
treatment for latent TB infection will be followed at 0, 6, 12, 18 and 24
months. This is an observational study, indicating that the results of the
novel comparative assay will not be used for clinical decision making. The
results of the QFT-G will be blinded until the end of the study. Standard care
will be provided according to existing protocol, e.g. chest radiography will be
performed in all persons with a positive TST.
Intervention
A blood sample (2 ml) will be collected at each time point during follow-up.
The study does not interfere with standard medical care.
Follow-up
Subjects with a positive TST who are treated will be seen at 0, 2, 6 and 12
months. Those who decline treatment will be followed at 0, 6, 12, 18 and 24
months.
Analysis
Descriptive summary statistics, time course of QFT-G results in relation to
treatment.
Study burden and risks
0
postbus 90.000
3509 AA Utrecht
Nederland
postbus 90.000
3509 AA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
military personnel of Dutch army
recent positive Mantoux
Exclusion criteria
known immune defect ( HIV), BCG vaccin, previous positive Mantoux
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13753.041.06 |