Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624501
Status:
COMPLETED
Last Update Posted:
None
First Post:
2019-03-05
Brief Title:
Integrated Discovery and Development of Innovative TB Diagnostics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Integrated Discovery and Development of Innovative TB Diagnostics
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CETR
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None