Non-invasive TB Triage and Patient Mapping Platform Using Breath Via Low-Cost Titanium Dioxide Nanotube Sensor

NCT02681445 | Completed DMC

• 1 other identifier: 00088349
• Study Type: observational
• Target: 810
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to evaluate the sensitivity and specificity of a nanotube-based point-of-care breath-based tuberculosis screening test as compared to the current standards of care including sputum microscopy, sputum culture, chest X-ray, and GeneXpert (MTB/RIF). The primary objective is to determine an initial estimate of the sensitivity and specificity of a nano-tube based point-of-care test for the diagnosis and screening of active pulmonary tuberculosis. Secondary objectives include the collection of user data to test and further develop the screening platform based on end-user feedback.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Correlation of sensor ability to detect breath biomarkers for TB

  Assess feasability of TB sensor to detect breath biomarkers from patients.

  12 Months

Study Arms (5)

Group 1 Healthy Non Smokers

No TB Symptoms No TB History Negative Mantoux test Normal Chest X-ray Non-Smoker

Device: Breath Collection

Group-2 Smokers

No TB History No TB Symptoms No TB History Negative Mantoux test Smoker 10 + Cigarettes/day

Device: Breath Collection

HIV Positive

No TB Symptoms No TB History Negative Mantoux test Normal Chest X-ray HIV Positive CD4 count \>200

Device: Breath Collection

TB Suspect Group

WHO Screening Recommendation Protocls Unexplained Cough Sputum production Fever Weight Loss or loss of appetite Night Sweats

Device: Breath Collection

Lower Respiratory Track Infection

TB Lab test Negative Ab Normal Chest X-ray HIV Negative

Device: Breath Collection

Interventions

Breath Collection DEVICE

breath will be collected from patients in breath bag for analysis for observational study.

Group 1 Healthy Non Smokers; Group-2 Smokers; HIV Positive; Lower Respiratory Track Infection; TB Suspect Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study type: Observational feasibility study * Study population: Non-pregnant adults over the age of 18 from the areas around Mumbai, India. Based upon records of these clinical sites, about 5% to 7% of the patients reporting at these hospitals are suspected to be TB positive. * Endpoint: Estimate of the diagnostic accuracy of a POC TB biomarker breath test (sensitivity, specificity). * Phase: Phase I (feasibility or pilot study) * Study sites: Multicenter trial (4 clinical sites in Mumbai, India) * Study groups: 5 * Sample Size (approx): 800 * Estimated enrollment time: 1 year

You may qualify if:

• No TB Symtoms No history of TB Negative Mantoux test Normal Chest X-ray HIV Negative

You may not qualify if:

• Prior history of TB

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Mahatma Gandhi Institute of Health Science

Navi Mumbai, India

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 12, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

IN (1)