Integrated Discovery and Development of Innovative TB Diagnostics

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.

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Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Disease Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for aim 1:

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.

Inclusion criteria

for aim 2:

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.

Exclusion criteria

Treatment and study plan

observational cohort study

Other

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Registry information

Acronym: (CETR)

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2020
First posted: Oct 3, 2024
Registry last updated: Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed