Bioaerosol Sampling in Suspected Pulmonary Tuberculosis

NCT04241809 | Completed

• 1 other identifier: R01AI147347-01
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) is transmitted in bioaerosols containing Mycobacterium tuberculosis (Mtb). Mtb-containing bioaerosols are likely related to host infectiousness and central to ongoing TB transmission. No routine diagnostic assay exists to measure Mtb in bioaerosols. Furthermore, published studies of Mtb in bioaerosol samples, have been limited to individuals with sputum-positive pulmonary TB. Currently TB diagnosis is based on clinical symptoms and sputum laboratory findings. However, approximately half of all patients commencing TB treatment are sputum negative resulting in a high proportion of presumptive treatments. We therefore propose to use a sensitive sampling protocol to investigate the prevalence of Mtb-containing bioaerosols in both sputum-positive and sputum-negative TB suspects.

Conditions

Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture

Outcome Measures

Primary Outcomes (1)

• Primary Aim

  The difference in prevalence proportions of Mtb-containing bioaerosol in sputum positive and sputum negative pulmonary TB cases (Groups A \& B)

  12 months

Secondary Outcomes (1)

• Secondary Aim (1)

  12 months

Other Outcomes (7)

• Exploratory Aim (1)

  12 months

• Exploratory Aim (2)

  12 months

• Exploratory Aim (3)

  12 months

Study Arms (3)

A: Notified TB with sputum laboratory confirmation

Bioaerosol Sampling: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect, following passive respiratory activity and environmental sampling. Repeat bioaerosol sampling will be conducted at 14 days.

Diagnostic Test: Bioaerosol Sampling

B: Notified TB without sputum laboratory confirmation

Bioaerosol Sampling: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect, following passive respiratory activity and environmental sampling. Repeat bioaerosol sampling will be conducted at 14 days.

Diagnostic Test: Bioaerosol Sampling

C: Not Notified for TB

Bioaerosol Sampling: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect, following passive respiratory activity and environmental sampling. Repeat bioaerosol sampling will be conducted at 14 days.

Diagnostic Test: Bioaerosol Sampling

Interventions

Bioaerosol Sampling DIAGNOSTIC_TEST

Cyclone collection of exhaled bioaerosol

A: Notified TB with sputum laboratory confirmation; B: Notified TB without sputum laboratory confirmation; C: Not Notified for TB

Eligibility Criteria

• Age: 13 Years - 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with respiratory and/or constitutional symptoms suggestive of pulmonary TB who self-present to two TB clinics in high density peri-urban settlements in Cape Town, South Africa will be offered recruitment to the study

You may qualify if:

• age over 13 years
• person with suspected TB
• provision of written, informed consent (parental consent and patient assent for those aged under 18yrs)

Sponsors & Collaborators

• Desmond Tutu HIV Foundation: lead
• National Institutes of Health (NIH): collaborator
• University of Cape Town: collaborator
• Zeteo Tech Incorporated: collaborator

Study Sites (1)

Aerobiology Research Centre

Cape Town, Western Cape, South Africa

Location

Related Publications (1)

• Patterson B, Koch A, Gessner S, Dinkele R, Gqada M, Bryden W, Cobelens F, Little F, Warner DF, Wood R. Bioaerosol sampling of patients with suspected pulmonary tuberculosis: a study protocol. BMC Infect Dis. 2020 Aug 8;20(1):587. doi: 10.1186/s12879-020-05278-y.

  PMID: 32770954 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mtb lipid and genomic containing respiratory bioaerosol

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: January 27, 2020
• Study Start: May 15, 2020
• Primary Completion: May 27, 2022
• Study Completion: May 27, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

ZA (1)