Metagenomics Next-generation Sequencing Approach to Detect Microbial DNA/RNA Overtime in Individuals Undergoing Hematopoietic Stem Cell Transplant

Infections are a major cause of morbidity and mortality in patients undergoing hematopoietic stem cell transplant (HSCT). The purpose of this study is to evaluate if metagenomic next-generation sequencing (mNGS) can detect microbial signatures in people undergoing HSCT, and if microbial identification can be correlated with clinical features of infection (e.g., fever). Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.

The primary objective of this study is to investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in immunocompromised patients undergoing transplantation.

Secondary objectives are to: (1) To correlate microbial identification with episodes of fever or clinical suspicion of infection; and to (2) correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.

The study is conducted at the NIH Clinical Center. Participants, aged 3 years and older, on other research studies at the NIH CC who are undergoing HSCT are invited to take part of this study. Expected participation is up to six months.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hematopoietic Stem Cell Transplantation

Age range

3 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

About this study

Study Description:

Participants undergoing HSCT as part of other studies at the NIH Clinical Center (CC) will provide blood before the transplant and through 6 months after. Total nucleic acid will be extracted from plasma and subjected to mNGS.

Objectives:

Primary:

To investigate if by using plasma and an mNGS approach, we can detect bacterial, fungal, protozoan, or viral DNA/RNA over time, in immunocompromised patients undergoing transplantation.

Secondary:

To correlate microbial identification with episodes of fever or clinical suspicion of infection.
To correlate change in microbial signatures in patients with suspected immune reconstitution inflammatory syndrome.

Endpoints:

Primary:

Comparison of mNGS results to routine clinical test results (microbiology and/or pathology)

Secondary:

Calculation of frequencies of different microbial identifications as it relates to the development of fever or microbiologically/clinically defined infection.
Changes in different microbial signatures over time

Who can participate

Healthy volunteers accepted: No

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

INCLUSION CRITERIA:

In order to be eligible to participate in this study; an individual must meet all the following criteria:

Male or female, aged 3 years or older.
Co-enrolled on another study at the NIH CC, under which they will undergo HSCT.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.

Exclusion criteria

An individual with any condition that, in the opinion of the investigator, contraindicates participation in this study, will be excluded.

Treatment and study plan

Primary outcomes

Any positive clinical results for each of 5 pathogen categories

Time frame: Six months

Research blood draw at screening, during fever episodes and at follow up days 30, 100 and 180 (+/- 7 days).

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 1, 2025
Registry last updated: Jul 24, 2026

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