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Verification and Validation of OmiX Molecular Diagnostic Technology Platform.

Verification and Validation of OmiX Molecular Diagnostic Technology Platform for Microbial Identification and Anti-microbial Resistance detection in Blood and Urine: A Prospective Study - OmiX

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018459
Enrollment
350
Registered
2019-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: A415- Sepsis due to other Gram-negativeorganisms

Interventions

None listed

Sponsors

OmiX Research and Diagnostics Laboratories Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients admitted to ICU and whose sample is sent for blood culture and for whom the blood culture comes positive will be included in the study. 2. Patients who are male or female are included in the study. 1. ICU Patients suspected of or with confirmed urinary tract infection will be included in the study. 2. The urine of the patient should have been/will be sent for culture 3. Patients who are male or female are included in the study. 4. Patients must be above 18 years of age and able to provide informed consent either themselves or through an appointed representative.

Exclusion criteria

Exclusion criteria: 1. Patient less than 18 years old 2. Patients not suspected to have sepsis or UTI

Design outcomes

Primary

MeasureTime frame
Verification and optimize the diagnostic test kits, devices and algorithms.Timepoint: Optimization of kit and test protocol: 1 month Validation: 4 months Data Analysis: 1 month

Secondary

MeasureTime frame
Detection of antimicrobial resistance genesTimepoint: Phase 2: Concordance phase

Countries

India

Contacts

Public ContactDr Harish MM

Mazumdar Shaw Medical Center

dr.harishmm@rocketmail.com9869250397

Outcome results

None listed

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