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OpenTrials
Completed

NCT Number: NCT06197269

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

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.

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Key information

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Hardinge Medical college

New Delhi, National Capital Territory of Delhi, 110001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Short duration antibiotics

Other

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

Standard duration antibiotics

Other

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

Primary outcomes

  1. Incidence of 'Treatment Failure'

    Time frame: 15 days of stopping antibiotics

    New onset appearance of clinical signs and symptoms requiring initiation of antibiotics

Secondary outcomes

  1. Mortality

    Time frame: Till 1 month of life

    Death due to any reason

  2. Need for additional courses of antibiotic therapy

    Time frame: Till 1 month of life

    Additional courses during the study time frame

  3. Length of hospital stay

    Time frame: From date of birth until date of death or discharge whichever come assessed till 1 month of life

    Duration of hospital stay

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Registry information

Official study title

Efficacy And Safety Of Short Course Antibiotic Therapy (72hrs) As Compared To Standard Duration (5-7 Days) Of Therapy In Preterm Neonates With Culture Negative Early Onset Sepsis: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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