Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis

Lady Hardinge Medical College

Status: Completed

Conditions: Antibiotic Stewardship; Early-Onset Neonatal Sepsis

Treatments: Other: Short duration antibiotics; Other: Standard duration antibiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT06197269

LHMC/IEC/2019/41

Details and patient eligibility

About

Objective of the study is to compare the efficacy and safety of 'Short duration antibiotic' (72hrs) and 'Standard duration antibiotic'(5 - 7days) in preterm neonates ( >28weeks and >1000grams ) with culture negative early onset sepsis.

Full description

Enrolled participants will be randomly allocated to one of two study groups: 1) Short duration antibiotic' (72hrs), 2) Standard duration antibiotic'(5 - 7days)

Short duration antibiotic group: Antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics

Standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.

Enrollment: 75 patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (All must be present)

• All Preterm neonates (Gestational age >28weeks and >1000grams)
• age less than 72hours of life
• Started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture
• Symptoms resolved at time of randomization

Exclusion Criteria:

• Antibiotics started based on risk factors
• Infants with major congenital anomalies or syndromes.
• Presence of site specific infections including meningitis, pneumonia
• Neonates suspected to have inborn errors of metabolism
• Neonates with Severe birth asphyxia, (Apgar score at 5min <4 and cord Ph< 7.0,base excess <-16)
• Neonates underwent major surgery in 1st week of life
• Deemed by Doctor in charge to be sick enough to be continued on antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

Short duration antibiotic

Experimental group

Description:

antibiotic therapy will be stopped at the time of randomization i.e. 72 hrs after starting treatment

Treatment:

Other: Short duration antibiotics

Standard duration antibiotic

Active Comparator group

Description:

Antibiotics will be continued for 5-7 days more, 72 hrs after starting treatment.

Treatment:

Other: Standard duration antibiotics