Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia

Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02856204

Enrollment

Registered

2016-08-04

Start date

2016-08-31

Completion date

2019-04-30

Last updated

2019-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Febrile Neutropenia

Brief summary

This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.

Detailed description

PRIMARY OBJECTIVES: I. To test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia. SECONDARY OBJECTIVES: I. To establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis. OUTLINE: Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.

Interventions

OTHERCytology Specimen Collection Procedure

Undergo collection of blood

OTHERLaboratory Biomarker Analysis

Correlative studies

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with febrile neutropenia * A primary diagnosis of acute myeloid leukemia (AML)

Exclusion criteria

* Prior history of febrile neutropenia

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen	Up to 6 weeks	—
Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics	Up to 6 weeks	Will be compared to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.
Number and frequency of novel pathogens found	Up to 6 weeks	—
Proportion of patients with mitochondrial DNA detected	Up to 6 weeks	—
Proportion of patients with false negative	Up to 6 weeks	—
Proportion of patients with false positives	Up to 6 weeks	—

Secondary

Measure	Time frame
Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics	Up to 6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026