To compare 7 days vs 14 days of antibiotics in neonatal bacterial infections.

Not Applicable

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

• Registration Number: CTRI/2022/08/044933
• Lead Sponsor: AIIMS Raipur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Neonates aged 0-28days, who are currently admitted to the neonatal unit of AIIMS RAIPUR.

2.Birth weight >1000g

3.Suspected septicemia for which a blood culture is sent and for which the treating clinician decides to start antibiotics

Exclusion Criteria

1.Central Nervous System infection (meningitis will be defined as one or more cerebrospinal fluid (CSF) cell count >25 microliters with >60% neutrophils: glucose <20 mg/dl or CSF: blood glucose <0.6 or protein >150 mg/dl in term or >180mg/dl in preterm or positive gram stain report or positive report culture.

2.Septic arthritis, osteomyelitis, or deep-seated abscess as clinically judged by the treating team

3.Life-threatening congenital malformations as judged by the principal investigator of the center.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Definite or probable relapse. Definite relapse is defined as the occurrence of an episode of illness within the 21 days after antibiotic completion in which the same organism with a similar antibiogram is grown as the original episode. Probable relapse is defined as the occurrence of an episode of illness within 21 days, when an episode is diagnosed to be a relapse of bacterial sepsis based on clinical features and investigations, in the setting of sterile blood culture. Probable relapse is adjudicated by a blinded pediatrician/neonatologist who is not associated with the rest of the study.Timepoint: 21days

Secondary Outcome Measures

Name	Time	Method
Definate or probable relapse within 21 or 28 days after antibiotic completion , <br/ ><br>2. Definate or probable relapse 28 or 35 days after randomization.Timepoint: 28 or 35 days after randomization.