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A clinical study to find out ability of Polymerase chain reaction test in detecting infection in neonates

Microbe detection rate by culture and Polymerase Chain reaction (PCR) in health care associated infections (HAI) in the setting of Neonatal Intensive Care unit (NICU)- A Descriptive study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/04/013358
Enrollment
196
Registered
2018-04-19
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: null- health care associated infections in neonates

Interventions

Intervention1: NIL: NIL

Sponsors

Vivek Raju
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with features of health care associated infections if both culture and PCR is sent before starting or changing antibiotics are included

Exclusion criteria

Exclusion criteria: 1.surgical condition 2. Antibiotic change based on a culture report

Design outcomes

Primary

MeasureTime frame
The microbe detection rate, measured as proportion of sample reported positive (on blood / CSF culture and PCR) out of total samples sentTimepoint: within 5 days of suspected infection—

Secondary

MeasureTime frame
1.Profile of microbes detected by blood / CSF culture and PCR 2.Incidence of fungal sepsis 3.Antibiotic resistance pattern 4.Increase in proportion of microbe detected by â??blood/ CSF culture and PCRâ?? among babies suspected to have HAI when compared with historical controls when blood culture alone was used. Timepoint: In an episode of suspected infection—

Countries

India

Contacts

Public ContactDr Naveen Jain

Kerala Institute of Medical Sciences

naveen_19572@hotmail.com9387814568

Outcome results

None listed

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