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Comparison of two courses [one long course-14 days, another short course-10 days] of antibiotic treatment for newborns suffering from sepsis.

Ten versus 14-days antibiotic therapy for culture-positive neonatal sepsis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/01/048780
Enrollment
234
Registered
2023-01-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

Health Condition 1: P369- Bacterial sepsis of newborn, unspecified

Interventions

Intervention1: Intravenous antibiotic for 10 days in culture-positive sepsis: Newborns with culture-positive sepsis will receive intravenous antibiotic for 10 days. Control Intervention1: Intravenous

Sponsors

Burdwan Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newborns developed culture-positive sepsis and showing the sign of remission at 9th day of antibiotic treatment.

Exclusion criteria

Exclusion criteria: Meningitis, abscess, osteomyelitis Gross congenital anomaly Fungal sepsis With central venous line Needs Mechanical ventilation/ inotropic support

Design outcomes

Primary

MeasureTime frame
Treatment Failure [Defined as re-infection with same organism/ or re-appearance of signs of sepsis]Timepoint: 4 week till discharge—

Secondary

MeasureTime frame
Complications (Bronchopulmonary dysplasia, retinopathy of prematurity, necrotising enterocolitis, intraventricular hemorrhage)Timepoint: 4 week till discharge;Death [Due to recurrent sepsis]Timepoint: 4 week till discharge;Hospital stayTimepoint: Till discharge—

Countries

India

Contacts

Public ContactDr Rajib Das

Burdwan Medical College

mail2rajib.das@gmail.com6294803073

Outcome results

None listed

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