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Ultralow Dose Computed Tomography in High-risk Drug-resistant Tuberculosis Contacts

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ClinicalTrials.gov Identifier: NCT02454738
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jin Mo Goo, Seoul National University Hospital

Brief Summary:
To evaluate CT abnormalities in the lung parenchyma in close contacts at high risk for developing multidrug- or extensively drug-resistant Tb by using a follow-up ultralow dose CT scan.

Condition or disease Intervention/treatment Phase
Latent Tuberculosis Radiation: Ultralow dose chest CT scan Not Applicable

Detailed Description:

Multidrug- or extensively resistant tuberculosis tuberculosis is a major public health threat worldwide and the global burden of drug-resistant tuberculosis is increasing. Drug-resistant tuberculosis is associated with long period and high costs for treatment, high rates of default, treatment failure and death.

Drug-resistant tuberculosis should be diagnosed rapidly so as to reduce potential transmission. In the United States, at least one-fifths cases of multidrug-resistant tuberculosis can be linked to transmission. Close contacts to drug-resistant tuberculosis are at high risk for being transmitted and developing drug-resistant tuberculosis. There are two options suggested for close contacts to drug-resistant tuberculosis: preventive therapy and close observation. But both strategies are lack of sufficient evidence.

Ultralow chest CT scan may be an alternative for early identification and risk stratification of developing active tuberculosis in close contacts to drug-resistant tuberculosis with minimal radiation exposure similar to that of chest x-ray.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ultralow Dose Computed Tomography in Close Contacts at High Risk for Developing Multidrug- or Extensively Drug-resistant Tuberculosis: A Pilot Study
Study Start Date : June 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Chest CT scan
Two follow-up ultralow dose chest CT scans will be taken 3 months and 1 year after the initial ultralow dose chest CT scan in close contact at high risk for developing multidrug- or extensively drug-resistant tuberculosis.
Radiation: Ultralow dose chest CT scan
Ultralow-dose chest CT scan is performed using a 64-row multidetector CT system (Discovery CT750HD; GE Healthcare, Waukesha, WI) with 1.25-mm-thick axial slices at less than 1 mSv (volume computed tomography dose index: 0.39 milligray).




Primary Outcome Measures :
  1. Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up. [ Time Frame: 3 months and 1 year after the initial CT scanning ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals who had household contact with or who had worked in the same rooms as patients with smear-positive, culture-proven multidrug-or extensively drug-resistant pulmonary tuberculosis for longer than 8 hours per day
  • Older than 20 years

Exclusion Criteria:

  • Pregnant women
  • Individuals with abnormality on chest x-ray suspected of active tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454738


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jin Mo Goo, M.D. Department of Radiology, Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin Mo Goo, Professor, Department of Radiology, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02454738    
Other Study ID Numbers: SNUHchestradiology-001
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Jin Mo Goo, Seoul National University Hospital:
pulmonary tuberculosis
chest
ultralow dose computed tomography
Additional relevant MeSH terms:
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Tuberculosis
Latent Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections