Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections (KDG-002)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03846804 |
Recruitment Status : Unknown
Verified July 2019 by James Wood, Indiana University.
Recruitment status was: Not yet recruiting
First Posted : February 20, 2019
Last Update Posted : July 5, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Musculoskeletal Infection Acute Hematogenous Osteomyelitis Septic Arthritis Osteomyelitis Pyomyositis | Diagnostic Test: Karius Test |
Study Type : | Observational |
Estimated Enrollment : | 38 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Plasma-Based Next-Generation Sequencing for Pathogen Detection and Quantification in Children With Musculoskeletal Infections |
Estimated Study Start Date : | September 1, 2019 |
Estimated Primary Completion Date : | March 15, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

- Diagnostic Test: Karius Test
Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections
- To evaluate and compare pathogen identification of children with musculoskeletalTo compare pathogen identification using the Karius Test and standard culture methods [ Time Frame: IP1- Within 48 hours of admission ]Pathogen identification (genus and species) by Karius Test vs. standard culture methods
- To evaluate and compare pathogen identification of children with musculoskeletalTo compare pathogen identification using the Karius Test and standard culture methods [ Time Frame: IP2- Within 48 hours of the admission sample ]Pathogen identification (genus and species) by Karius Test vs. standard culture methods
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers at admission [ Time Frame: IP1- Within 48 hours of admission ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers at admission [ Time Frame: IP2- Within 48 hours of the admission sample ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers [ Time Frame: IP3- Within 48 hours of the second inpatient sample ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers [ Time Frame: IP4- Within 48 hours of the third inpatient sample ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers [ Time Frame: OP1- 1-2 weeks after hospital discharge ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers [ Time Frame: OP2- 3-6 weeks after hospital discharge ]Quantification of cfDNA in molecules per microliter (MPM)
- Compare the quantity of cfDNA to clinical symptoms and inflammatory markers [ Time Frame: OP3- 6-8 weeks after hospital discharge ]Quantification of cfDNA in molecules per microliter (MPM)
- Evaluate whether admission sample quantitative cfDNA predicts severe disease in children with MSKI [ Time Frame: From hospital admission to hospital discharge, up to 3 months ]Determine the correlation of cfDNA level in MPM to severity of infection
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 6 months (to ensure adequate blood volume drawn) to 18 years of age.
- Strong clinical suspicion of MSKI as evidenced by fever, osteoarticular pain (e.g. tenderness to palpation of a joint, bone pain, or refusal to bear weight); and elevated ESR or CRP.
Exclusion Criteria:
- Subjects will be excluded if they have clinical evidence suggesting an alternative diagnosis; inability or unwillingness to consent for the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03846804
Contact: James B Wood, MD, MSCI | 317-278-9612 | woodjb@iu.edu | |
Contact: Carrie Nijak, RN | 317-274-8804 | canijak@iu.edu |
Principal Investigator: | James Wood, MD, MSCI | Indiana University School of Medicine - Pediatrics |
Responsible Party: | James Wood, Assistant Professor of Pediatrics, Indiana University |
ClinicalTrials.gov Identifier: | NCT03846804 |
Other Study ID Numbers: |
1901296571 |
First Posted: | February 20, 2019 Key Record Dates |
Last Update Posted: | July 5, 2019 |
Last Verified: | July 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
infection plasma based next generation sequencing blood culture |
tissue culture joint fluid culture pathogen identification |
Infections Communicable Diseases Osteomyelitis Arthritis, Infectious Pyomyositis Disease Attributes Pathologic Processes Arthritis Joint Diseases |
Musculoskeletal Diseases Bone Diseases, Infectious Bone Diseases Suppuration Myositis Muscular Diseases Neuromuscular Diseases Nervous System Diseases |