Latent Tuberculosis InfectionLTBINCT00804713
Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
A study testing BST, TST and QFT in people with Latent Tuberculosis Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis Infection
- What is being tested?
- BST, TST and QFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,017 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson
Who cannot join
- If they have history of severe reactions to TST (e.g., blistering, scar, or symptoms of immediate hypersensitivity)
- If they are unwilling to provide written consent for the study
- If they are unwilling to provide Health Insurance Portability and Accountability Act (HIPAA) authorization
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.
- Conditions
- Latent Tuberculosis Infection
- Being tested
- BST, TST, QFT, T-spot
- Keywords
- TB, tuberculosis diagnosis, TB screening
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSTDrug
0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method.
TSTDrug
Administer TB Skin test (TST)
QFTOther
Also called Quantiferon Gold-in-tube (QFT)
Perform QFT TB test
T-spotOther
Also called T-spot.TB test
Perform T-Spot TB test
| Study group | Role | What they receive |
|---|---|---|
| All study participants | Experimental | Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot Receives: Drug: BST; Drug: TST; Other: QFT; Other: T-spot |
What is being measured
The primary outcome is the main question the study is designed to answer.
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.)
The number of 1803 is used here because that is the number for which valid results were available for all 4 tests.
The number presented in each category is the number of participants that had positive results.
We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol.
Measured: 48-72 hrs post administration
Secondary outcomes (1)
Positive QFT-GIT Result
The number of subjects is 1781 (less than the original 1978) because we analyzed only those who had valid results by all 4 tests to have a fair comparison. Additionally, we excluded those subject who had a borderline T-Spot result, as we were not able to make valid comparisons with these results.
Measured: 48-72 hours after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent Tuberculosis InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program
- Responsible party
- Sponsor
- Investigators
- James Mancuso, MD MPH, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804713
- Sponsor's protocol ID
- IDCRP-021
- Acronym
- LTBI
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2008
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mancuso JD, Tribble D, Mazurek GH, Li Y, Olsen C, Aronson NE, Geiter L, Goodwin D, Keep LW. Impact of targeted testing for latent tuberculosis infection using commercially available diagnostics. Clin Infect Dis. 2011 Aug 1;53(3):234-44. doi: 10.1093/cid/cir321.
PubMed 21765072
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Latent Tuberculosis Infection (LTBI) in US Army Recruits
- ClinicalTrials.gov ID
- NCT00804713
- Acronym / sponsor ID
- LTBI / IDCRP-021
- Conditions
- Latent Tuberculosis Infection
- Keywords
- TB, tuberculosis diagnosis, TB screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,017 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Infectious Diseases Clinical Research Program
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 9 Dec 2008 (estimated)
- Results
- Posted 15 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to assess the feasibility and potential impact of using a targeted testing approach and 2 interferon-gamma release assays (IGRA) to screen for latent tuberculosis (TB) infection (LTBI) among military recruits. The current policy of universal application of the Mantoux tuberculin skin test (TST) to screen for LTBI may result in many TST reactions among recruits who are at low risk for LTBI. The central hypothesis is that targeted testing by use of the questionnaire will reduce unnecessary testing of low-risk recruits without affecting the identification of higher-risk recruits. The secondary hypothesis is that many discordant results between the TST and IGRA may be explained by cross-reactivity to non-tuberculous mycobacteria (NTM) with the TST.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | Experimental | Drug: BST, Drug: TST, Other: QFT, Other: T-spotSubjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any recruit, age 18 years or older, undergoing routine entry-level medical processing at Fort Jackson
Key exclusion criteria (3 listed)
- If they have history of severe reactions to TST (e.g., blistering, scar, or symptoms of immediate hypersensitivity)
- If they are unwilling to provide written consent for the study
- If they are unwilling to provide Health Insurance Portability and Accountability Act (HIPAA) authorization
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 |
|---|---|---|
| BST0.1 mcg/mL (1 dose) Battey skin test (BST) antigen administered using the Mantoux method. | Drug | All study participants |
| TSTAdminister TB Skin test (TST) | Drug | All study participants |
| QFTAlso: Quantiferon Gold-in-tube (QFT)Perform QFT TB test | Other | All study participants |
| T-spotAlso: T-spot.TB testPerform T-Spot TB test | Other | All study participants |
Primary outcome
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines.
Time frame: 48-72 hrs post administration
Risk stratification and test result. Risk was stratified by the use of risk factors identified by questionnaire according to the 5, 10 and 15 mm criteria (CDC Morbidity and Mortality Weekly Report Recommendations and Reports 2000. Targeted Testing for Latent Tuberculosis Infection.) The number of 1803 is used here because that is the number for which valid results were available for all 4 tests. The number presented in each category is the number of participants that had positive results. We are only presented a risk stratified interpretation for the TST (not the QFT, T-spot, and BST) because that is the only test for which this methodology is accepted in scientific and medical use. It is also the only test for which we had pre-specified the use of this methodology in the protocol.
1 secondary outcome
Positive QFT-GIT Result
Time frame: 48-72 hours after enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21765072Mancuso JD, Tribble D, Mazurek GH, Li Y, Olsen C, Aronson NE, Geiter L, Goodwin D, Keep LW. Impact of targeted testing for latent tuberculosis infection using commercially available diagnostics. Clin Infect Dis. 2011 Aug 1;53(3):234-44. doi: 10.1093/cid/cir321.
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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.
James Mancuso, MD MPH principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BST, TST and QFT in people with Latent Tuberculosis Infection, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 29 Mar 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TST Induration Will be Interpreted Relative to Risk, in Accordance With Published CDC Guidelines. (time frame: 48-72 hrs post administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00804713, which also lists 1 linked publication.
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 29 Mar 2023.