Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without CultureNCT04241809
Bioaerosol Sampling in Suspected Pulmonary Tuberculosis
An observational study of Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 100 years
- Conditions the study is for
- Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture
- What is being tested?
- Bioaerosol Sampling
- How many people
- 102 participants
- Where
- 1 siteSouth Africa
- Study dates
- 15 May 2020to 27 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 100 years
- All sexes
- Child, Adult, Older adult
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
Who may be able to join
- age over 13 years
- person with suspected TB
- provision of written, informed consent (parental consent and patient assent for those aged under 18yrs)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioaerosol Sampling of Patients With Suspected Pulmonary Tuberculosis: A Study Protocol
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.
Read the 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.
- Being tested
- Bioaerosol Sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioaerosol SamplingDiagnostic test
Cyclone collection of exhaled bioaerosol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Bioaerosol Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Aim
The difference in prevalence proportions of Mtb-containing bioaerosol in sputum positive and sputum negative pulmonary TB cases (Groups A \& B)
Measured: 12 months
Secondary outcomes (1)
Secondary Aim (1)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 May 2020
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without CultureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desmond Tutu HIV Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Cape Town, Zeteo Tech, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241809
- Sponsor's protocol ID
- R01AI147347-01
- Status last verified
- Mar 2023
- First submitted
- 27 Nov 2019
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32770954
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioaerosol Sampling of Patients With Suspected Pulmonary Tuberculosis: A Study Protocol
- ClinicalTrials.gov ID
- NCT04241809
- Acronym / sponsor ID
- R01AI147347-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Desmond Tutu HIV FoundationUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Cape Town, Zeteo Tech, Inc.
- Study start
- 15 May 2020 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A: Notified TB with sputum laboratory confirmation | – | Diagnostic Test: Bioaerosol SamplingBioaerosol 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. |
| B: Notified TB without sputum laboratory confirmation | – | Diagnostic Test: Bioaerosol SamplingBioaerosol 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. |
| C: Not Notified for TB | – | Diagnostic Test: Bioaerosol SamplingBioaerosol 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. |
Who may qualify
- Ages
- 13 to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- age over 13 years
- person with suspected TB
- provision of written, informed consent (parental consent and patient assent for those aged under 18yrs)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioaerosol SamplingCyclone collection of exhaled bioaerosol | Diagnostic test | A: Notified TB with sputum laboratory confirmation, B: Notified TB without sputum laboratory confirmation, C: Not Notified for TB |
Primary outcome
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)
1 secondary outcome
Secondary Aim (1)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Derived from this study: PubMed 32770954Patterson 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Tuberculosis Confirmation by Sputum Microscopy With or Without Culture, run by Desmond Tutu HIV Foundation at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Aim (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04241809, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.