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Evaluation of biomarkers like CRP and CBC to distinguish bacterial infections in Ujjain, India

Evaluation of biomarkers to distinguish bacterial vs non-bacterial infections in Ujjain, India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/05/019437
Enrollment
1000
Registered
2019-05-30
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: R509- Fever, unspecified

Interventions

None listed

Sponsors

Upssala University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Patients between 2 months and 65 years of age with acute fever defined as one or both of the following: greater than 37.5C axillary temperature measured electronically at initial evaluation or history of fever in the last 48 hours by the patient or their parent/caregiver. Presenting at the pediatric or general medicine outpatient department from 9.00 to 13.00 Monday to Saturday. Informed consent. Able and willing to be contacted for follow-up, if required approximately 2 weeks after enrollment.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: Children or adults who are assessed to be critically ill based on clinician assessment or the presence of any general signs of critical illness. This includes in adults, (but is not limited to), impending airway obstruction, central cyanosis, severe respiratory distress, feeble pulse, active seizures or recent history of seizures, or unconsciousness. In children this includes: extensive vomiting, active seizure or recent history of seizures, altered mentation, inability to feed, or any of the severe IMNCI classifications or a weight of less than 4 kilograms .

Design outcomes

Primary

MeasureTime frame
1. Performance characteristics (sensitivity, specificity, negative predictive value, positive predictive value, and area under the Receiver Operator Characteristic curve (AUC)) for CRP in comparison with reference diagnosis of bacterial infection based on microbiology, clinical assessment and expert review. 2. Appropriate CRP cut-off levels to aid in identifying bacterial infections in India.Timepoint: 4 months

Secondary

MeasureTime frame
1. Exploratory subset analysis of performance characteristics, i.e., age-specific diagnostic accuracy, or etiology-specific diagnostic accuracy, as appropriate. 2. Epidemiological fever data for the study sites. 3. Correlation of provisional diagnosis and antibiotic prescription with final classification of cause of fever.Timepoint: 4 months

Countries

India

Contacts

Public ContactAshish Pathak

R D Gardi Medical College

drashish.jpathak@gmail.com9302239899

Outcome results

None listed

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