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

Recruiting

• Conditions: Hematopoietic Stem Cell Transplantation

• Registration Number: NCT06904053
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

Detailed Description

Study Description:

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.

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:

1. To correlate microbial identification with episodes of fever or clinical suspicion of infection.

2. 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:

1. Calculation of frequencies of different microbial identifications as it relates to the development of fever or microbiologically/clinically defined infection.

2. Changes in different microbial signatures over time

Study Timeline

• Study First Submitted: 2025-03-29
• Study First Submitted QC: 2025-03-29
• Study First Posted: 2025-04-01
• Status Verified: 2025-04-08
• Study Start: 2025-04-09
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2027-11-01
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any positive clinical results for each of 5 pathogen categories	Six months	Research blood draw at screening, during fever episodes and at follow up days 30, 100 and 180 (+/- 7 days).

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States