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Study to find if a new test can identify blood infections in children more quickly.

Evaluation of Next Generation Sequencing (Bactfast ) as first line test for diagnosis of sepsis in pediatric patients in comparison with standard blood culture method. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111535
Enrollment
200
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

Medisequence Private Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Suspected diagnosis of sepsis for whom blood culture is collected. Written consent obtained from parents

Exclusion criteria

Exclusion criteria: Sample for Next generation Sequencing test ( BactFast) was collected beyond the 6 hour from the time of blood culture. Sample for Next generation Sequencing test ( BactFast)stored for more than 24 hours before testing. Sample collected without adhering to blood drawing guidelines for Bactfast Hemolysed or clotted blood samples

Design outcomes

Primary

MeasureTime frame
Diagnostic yield (positivity rate) of Bactfast compared to blood culture. (Proportion of samples in which a pathogen is detected by Bactfast compared to standard blood culture in pediatric patients with suspected sepsis.) Time taken from sample collection to identification of the pathogen by Bactfast compared to blood culture. Agreement between the two methods in identifying the same pathogen in the same patients sample. Timepoint: 6 months

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Sulochana Putli Bai

Kanchi Kamakoti CHILDS Trust Hospital

dr.sulochana@kkcth.org8754460674

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026