FindTrial
Sign In

Development of test methodology in Neonates

Development of PCR based test for Early Diagnosis of Invasive Candida Infections in Neonates - Nil

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/12/098965
Enrollment
100
Registered
2025-12-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: B377- Candidal sepsis

Interventions

Intervention1: Nil: Nil

Sponsors

Government of Institute of Medical Sciences (GIMS)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Neonates admitted in NICU and SNCU of GIMS and suspected to have fungal infection. Components of the history, physical exam, and clinical presentation that suggest subsequent development of invasive candida infection 2.Willingness to provide informed consent.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

MeasureTime frame
1.To develop PCR primers for prevalent candida pathogens in the NICU setting. 2.To compare the in-house developed PCR based assay with standard blood culture for diagnosing candida sepsis in neonates. Timepoint: At the baseline time of Enrollment only—

Secondary

MeasureTime frame
1.To compare the turnaround time of PCR-based assays & traditional blood culture methods.Timepoint: At the baseline time of Enrollment only—

Countries

India

Contacts

Public ContactDrRitu Sharma

Government Institute of Medical Sciences (GIMS)

drvarun21@gmail.com9650430879

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026