Trials / Completed
CompletedNCT06624501
Integrated Discovery and Development of Innovative TB Diagnostics
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,450 (actual)
- Sponsor
- Harvard University Faculty of Medicine · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational cohort study |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2018-02-28
- Completion
- 2020-02-28
- First posted
- 2024-10-03
- Last updated
- 2024-10-03
Source: ClinicalTrials.gov record NCT06624501. Inclusion in this directory is not an endorsement.