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

Not Applicable

Completed

• Conditions: Latent Tuberculosis
• Interventions: Radiation: Ultralow dose chest CT scan

• Registration Number: NCT02454738
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-22
• Study First Posted: 2015-05-27
• Study Start: 2015-06
• Status Verified: 2016-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chest CT scan	Ultralow dose 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.

Primary Outcome Measures

Name	Time	Method
Interval change of CT abnormalities potentially suggesting active tuberculosis in the lung parenchyma during the follow-up.	3 months and 1 year after the initial CT scanning

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of