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Development of new test for diagnosis of infections in patients with liver disease

Development and validation of novel Candida Leucine aminopeptidase 2 based immunoassay for the diagnosis and prognosis of invasive candidiasis among patients with cirrhosis - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/086551
Enrollment
410
Registered
2025-05-08
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Indian Council Of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 Patients with cirrhosis and suspected invasive candidiasis

Exclusion criteria

Exclusion criteria: All patients with: 1. Haematological (acute or chronic myelogenous/ lymphocytic leukaemia, multiple myeloma, lymphoma)and other malignancies 2. congenital or acquired immune deficiency 3. patients on chemotherapy

Design outcomes

Primary

MeasureTime frame
To develop a simple Enzyme linked immunosorbent assay for the detection of Candida LAP2 antigen in patient samples for the diagnosis of IC among cirrhosis patients with suspected Invasive candidiasisTimepoint: 30 months—

Secondary

MeasureTime frame
To validate the optimized assay including patients from multiple centers to confirm its diagnostic performance for IC diagnosis in a pragmatic setting.Timepoint: 31-36 month—

Countries

India

Contacts

Public ContactDr Nipun Verma

Post Graduate Institute of Medical Education and Research, Chandigarh, India

nipun29j@gmail.com09914208562

Outcome results

None listed

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