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Completed

NCT Number: NCT04241809

Bioaerosol Sampling in Suspected Pulmonary Tuberculosis

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.

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Key information

Conditions

Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture

Age range

13 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aerobiology Research Centre

Cape Town, Western Cape, South Africa

About this study

Our pragmatic, parallel-group design is aimed at identifying viable Mtb in bioaerosols produced by individuals attending a TB clinic in Cape Town, South Africa. Bioaerosol sampling will be performed on all eligible individuals presenting with symptoms indicative of TB and repeated at 14 days if initially positive for viable Mtb. Participants will be classified into three distinct groups based on the National TB Control Program (NTBCP) criteria: Group A, TB notification with sputum-based laboratory confirmation; Group B, TB notification with empiric diagnosis; and Group C, individuals not notified. Group C individuals with detectable Mtb bioaerosol will be monitored until resolution of clinical and laboratory status. Collection of bioaerosol specimens will be via two consecutive sampling modalities: (1) direct sampling of a specific respiratory manoeuvre; and (2) indirect sampling following passive respiratory activity and environmental sampling. microscopy. Mtb genomes and mycobacterial and host lipids will be detected using droplet digital PCR and mass spectrometry analyses, respectively. The primary objective is to determine the prevalence of Mtb bioaerosols in all TB clinic attendees and in each of the mutually exclusive groups A, B and C. Secondary objectives are to investigate differences in prevalence of Mtb bioaerosol by HIV status, current isoniazid preventive therapy (IPT) use and pre and post initiation of anti-TB chemotherapy.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Bioaerosol Sampling

Diagnostic Test

Cyclone collection of exhaled bioaerosol

Primary outcomes

  1. Primary Aim

    Time frame: 12 months

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

Secondary outcomes

  1. Secondary Aim (1)

    Time frame: 12 months

    The difference in numbers of viable MTB organisms in bioaerosols per liter of air sampled and per nano-liter of bioaerosol particulate volume collected in both sputum positive and sputum negative pulmonary TB cases (Groups A & B).

Other outcomes

  1. Exploratory Aim (1)

    Time frame: 12 months

    The prevalence of MTB containing bioaerosols in TB suspects not diagnosed with clinical TB (Group C)

  2. Exploratory Aim (2)

    Time frame: 12 months

    The difference in prevalence and numbers of viable MTB in subjects receiving and not receiving IPT prophylaxis.

  3. Exploratory Aim (3)

    Time frame: 12 months

    The difference in prevalence and numbers of viable MTB in subjects with and without HIV-infection.

  4. Exploratory Aim (4)

    Time frame: 12 months

    The difference in prevalence and numbers of viable MTB in subjects before and after TB therapy.

  5. Exploratory Aim (5)

    Time frame: 12 months

    The difference in numbers of viable MTB in bioaerosol collected by direct and indirect sampling.

  6. Exploratory Aim (6)

    Time frame: 12 months

    The ratio of MTB genomes (ddPCR) to viable MTB organisms (DMN-tre-positive) in MTB containing bioaerosol

  7. Exploratory Aim (7)

    Time frame: 12 months

    Which MTB lipids are present in MTB containing bioaerosol

Sponsors and collaborators

Lead sponsor

Desmond Tutu HIV Foundation

Other

Collaborators

  • National Institutes of Health (NIH)
  • University of Cape Town
  • Zeteo Tech, Inc.

Registry information

Official study title

Bioaerosol Sampling of Patients With Suspected Pulmonary Tuberculosis: A Study Protocol

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2020
Registry last updated
Mar 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.