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Bioaerosol Sampling in Suspected Pulmonary Tuberculosis

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ClinicalTrials.gov Identifier: NCT04241809
Recruitment Status : Not yet recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Zeteo Tech LLC
National Institutes of Health (NIH)
Institute of Infectious Disease, University of Cape Town
Information provided by (Responsible Party):
Desmond Tutu HIV Foundation

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.

Condition or disease Intervention/treatment
Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture Diagnostic Test: Bioaerosol Sampling

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bioaerosol Sampling of Patients With Suspected Pulmonary Tuberculosis: A Pragmatic Study Protocol
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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
Cyclone collection of exhaled bioaerosol

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
Cyclone collection of exhaled bioaerosol

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
Cyclone collection of exhaled bioaerosol




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Mtb lipid and genomic containing respiratory bioaerosol


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   13 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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)

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): NCT04241809


Contacts
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Contact: Robin Wood, DSc +27214066806 robin.wood@hiv-research.org.za
Contact: Sandesh Baiju +27810457400 Sandesh.Baiju@hiv-research.org.za

Sponsors and Collaborators
Desmond Tutu HIV Foundation
Zeteo Tech LLC
National Institutes of Health (NIH)
Institute of Infectious Disease, University of Cape Town
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Responsible Party: Desmond Tutu HIV Foundation
ClinicalTrials.gov Identifier: NCT04241809    
Other Study ID Numbers: R01AI147347-01 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The outcomes of the analysis in addition to the unprocessed data will be submitted for publication in open-source peer-reviewed journals and presented at international conferences.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections