Tuberculosis, Pulmonary(CETR)NCT06624501
Integrated Discovery and Development of Innovative TB Diagnostics
An observational study of Tuberculosis, Pulmonary, run by Harvard University Faculty of Medicine.
Trial summary
The long term goal of this project is to provide information critical to the development and use of a low-cost, point-of-care, rapid, simple, and highly accurate diagnostic tool that can help clinicians make a microbiological diagnosis in children who present with signs and symptoms suggestive of TB. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- Observational cohort study
- How many people
- 1,450 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 28 Feb 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will comprise (1) children (0-14 years) with symptoms of tuberculosis disease (TB) and (2) adults >18 years of age with a diagnosis TB. All participants will be recruited from Lima, Peru.
Who may be able to join
- Children must meet all of the following criteria at the time of enrollment to participate:
- Age < 15 years;
- Presents to a participating health center;
- Meets the Criteria for Enrollment of Children Into TB Diagnostic Evaluation Studies
- Has a history of contact with an adult with TB disease; and
- A guardian provides informed consent for minor to participate and, if age 8 to 14 years, the minor also provides assent.
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- Inclusion criteria for children who participate in Aim 2 will be the same as for those for Aim 1. Adults who participate in Aim 2 must meet all of the following criteria at the time of enrollment to participate.
- Age ≥ 18 years;
- Presents to a participating health center;
- Is diagnosed with incident pulmonary TB;
- Has sputum smear microscopy results;
- Has not yet initiated tuberculosis treatment; and
- Is willing to receive a rapid HIV test.
Who cannot join
- -
About this study
The long term goal of this project is to provide information critical to the development and use of a low-cost, point-of-care, rapid, simple, and highly accurate diagnostic tool that can help clinicians make a microbiological diagnosis in children who present with signs and symptoms suggestive of TB.
Specific aim 1: To identify the types of patient samples from which to best detect Mtb DNA in children with TB. We propose to obtain serial samples of sputum, blood, stool, and gastric and nasopharyngeal secretions from children with symptomatic TB and to use molecular methods to characterize the distribution of Mtb in these samples. The results of this study will allow us to identify the most promising sampling strategies for diagnosis of TB in children so that optimization of these easily-accessible samples for detection of Mtb nucleic acids can be addressed.
Read more
Specific aim 2: To determine whether cell free Mtb DNA can be detected in plasma and urine samples of children and adults with TB and to describe the host-related factors that alter the sensitivity of this assay. We propose to test serial urine and plasma samples for Mtb DNA fragments in two groups: (1) children with symptoms of TB and (2) adults with TB. Here, we will optimize sample volume sizes and of state-of-the-art sequencing tools to improve DNA recovery and detection. This study will help identify optimal samples and strategies for the non-invasive diagnosis of Mtb using urine.
Secondary aim: To create a bank of archived specimens for (1) optimization of Mtb DNA purification, extraction, and (2) use in future pediatric TB diagnostic research.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- Observational cohort study
- Keywords
- pediatric, diagnostic, cell-free DNA, molecular, tuberculosis
- Medical subject headings
- Tuberculosis, Pulmonary, Disease, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational cohort studyOther
| Study group | Role | What they receive |
|---|---|---|
| Children and adults | Children with symptoms of TB and adults with smear-positive or smear-negative pulmonary TB. Receives: Other: Observational cohort study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity for detection of Mtb, by sample type
For each type of biologic specimen, the proportion of samples in which Mtb could be isolated by DNA detection methods (sensitivity) relative to the standard of care (a combination of sputum smear, sputum culture, signs and symptoms).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 May 2015
- Primary completion28 Feb 2018
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies 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
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Molly Franke, Harvard University Faculty of Medicine
- Investigators
- Molly F. Franke, ScD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624501
- Sponsor's protocol ID
- 5U19AI109755-04
- Acronym
- (CETR)
- Status last verified
- Aug 2020
- First submitted
- 5 Mar 2019
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Discovery and Development of Innovative TB Diagnostics
- ClinicalTrials.gov ID
- NCT06624501
- Acronym / sponsor ID
- (CETR) / 5U19AI109755-04
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- pediatric, diagnostic, cell-free DNA, molecular, tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 3 Oct 2024 (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.
The long term goal of this project is to provide information critical to the development and use of a low-cost, point-of-care, rapid, simple, and highly accurate diagnostic tool that can help clinicians make a microbiological diagnosis in children who present with signs and symptoms suggestive of TB.
Specific aim 1: To identify the types of patient samples from which to best detect Mtb DNA in children with TB. We propose to obtain serial samples of sputum, blood, stool, and gastric and nasopharyngeal secretions from children with symptomatic TB and to use molecular methods to characterize the distribution of Mtb in these samples. The results of this study will allow us to identify the most promising sampling strategies for diagnosis of TB in children so that optimization of these easily-accessible samples for detection of Mtb nucleic acids can be addressed.
Specific aim 2: To determine whether cell free Mtb DNA can be detected in plasma and urine samples of children and adults with TB and to describe the host-related factors that alter the sensitivity of this assay. We propose to test serial urine and plasma samples for Mtb DNA fragments in two groups: (1) children with symptoms of TB and (2) adults with TB. Here, we will optimize sample volume sizes and of state-of-the-art sequencing tools to improve DNA recovery and detection. This study will help identify optimal samples and strategies for the non-invasive diagnosis of Mtb using urine.
Secondary aim: To create a bank of archived specimens for (1) optimization of Mtb DNA purification, extraction, and (2) use in future pediatric TB diagnostic research.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adults | – | Other: Observational cohort studyChildren with symptoms of TB and adults with smear-positive or smear-negative pulmonary TB. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise (1) children (0-14 years) with symptoms of tuberculosis disease (TB) and (2) adults >18 years of age with a diagnosis TB. All participants will be recruited from Lima, Peru.
Key inclusion criteria (13 listed)
- Children must meet all of the following criteria at the time of enrollment to participate:
- Age < 15 years;
- Presents to a participating health center;
- Meets the Criteria for Enrollment of Children Into TB Diagnostic Evaluation Studies
- Has a history of contact with an adult with TB disease; and
Key exclusion criteria (1 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 |
|---|---|---|
| Observational cohort study | Other | Children and adults |
Primary outcome
Sensitivity for detection of Mtb, by sample type
Time frame: Baseline
For each type of biologic specimen, the proportion of samples in which Mtb could be isolated by DNA detection methods (sensitivity) relative to the standard of care (a combination of sputum smear, sputum culture, signs and symptoms).
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 3 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Molly F. Franke, ScD principal investigator
Harvard Medical School (HMS and HSDM)
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Harvard University Faculty of Medicine.
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 13 inclusion and 1 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Sensitivity for detection of Mtb, by sample type (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.