- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03280147
7 Days Versus 14 Days of Antibiotics for Neonatal Sepsis
Comparison of the Efficacy of a 7-day Versus 14-day Course of Intravenous Antibiotics in the Treatment of Uncomplicated Neonatal Bacterial Sepsis: a Randomized Controlled Non-inferiority Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Reeta Rasaily
- Phone Number: +91-9818635958
- Email: reeta.rasaily@gmail.com
Study Locations
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Chandigarh, India, 160023
- Postgraduate Institute of Medical Education and Research
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New Delhi, India, 110001
- Kalawati Saran Childrens Hospital and Lady Hardinge Medical College
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New Delhi, India, 110031
- Chacha Nehru Bal Chikitsalaya
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Haryana
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Rohtak, Haryana, India, 124001
- Pandit BD Sharma Postgraduate Institute of Medical Sciences
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Karnataka
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Bangalore, Karnataka, India, 560029
- Indira Gandhi Institute of Child Health
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Tamil NADU
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Chennai, Tamil NADU, India, 600008
- Madras Medical College (for Institute of Obstetrics and Gynaecology)
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India, 226003
- King Georges Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Inclusion criteria for the initial observation part of study preceding randomization
- Neonates aged 0-28 days, either inborn or outborn, who are currently admitted in the Neonatal Unit of the centre.
- Whose birth weight is greater than or equal to1000 grams (it should be reliably ascertained from records of a hospital)
- Whose residence is within approximately 15 kms from the center, so that the infant can be brought back to the center for follow-up
- Who have suspected septicemia for which a conventional or BACTEC/BACTALERT blood culture is sent and for which the treating physician decides to start antibiotics
Inclusion criteria for Randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Positive blood culture other than Staphylococcus aureus
- No signs and symptoms of sepsis from end of day 5 through end of day 7 of starting sensitive antibiotics
Exclusion Criteria:
Exclusion criteria for the initial observation part of study preceding randomization:
- Central Nervous System infection (Central Nervous System infection (meningitis will be defined as CSF Cells >25 per uL with polys >60% OR [(CSF glucose <20 mg/dL OR CSF:blood* glu ratio <0.6) AND (CSF protein >150 mg/dL in term OR >180 mg/dL in preterm)]
- Septic arthritis, osteomyelitis or deep-seated abscess as clinically judged by the treating team
- Life threatening congenital malformations as judged by the principal investigator of the centre
Exclusion criteria for randomization applicable after 7 days of therapy of above patients with sensitive antibiotics:
- Sterile blood culture
- Suspected contaminants in blood culture.
- Growth of Staphylococcus aureus in blood culture
- Growth of fungal organism in blood culture
- Diagnosis of meningitis, septic arthritis, osteomyelitis, abscess
- Has not gone into remission on day 5 or have recurrence of symptoms from day 5 through day 7
- If the empiric antibiotic is resistant but neonate has shown improvement of signs and symptoms of sepsis and there is ambiguity regarding in vivo sensitivity of antibiotic use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 7-day course of antibiotics
Randomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria.
Those who are randomized to the 7-day group will not receive any further antibiotics.
|
Subjects in the "7-day course of antibiotics" arm of the study will receive no further antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization.
The choice of antibiotics would be guided by the blood culture and sensitivity report.
Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports.
Hence, names of specific antibiotics and/or their brand names have not been mentioned.
|
Active Comparator: 14-day course of antibiotics
Randomization of subjects will be performed at the end of 7 days of sensitive intravenous antibiotic administration, provided the subjects meet randomization criteria.
Those who are randomized to the 14-day group will receive 7 more days of the same antibiotics, to make it a total of 14 days.
|
Subjects in the "14-day course of antibiotics" arm of the study will receive 7 more days of antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization.
The choice of antibiotics would be guided by the blood culture and sensitivity report.
Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports.
Hence, names of specific antibiotics and/or their brand names have not been mentioned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Definite or probable relapse within 21 days post-antibiotic completion as per protocol
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
|
Among participants who adhered to study protocol- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-21 days after the end of the planned antibiotic therapy
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Definite or probable relapse within 21 days post-antibiotic completion as per intention to treat
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
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Among all randomized patients- Definite relapse: Episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode, Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
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From 0-21 days after the end of the planned antibiotic therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Definite relapse within 21 days post-antibiotic completion, as per protocol
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
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From 0-21 days after the end of the planned antibiotic therapy
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Definite relapse within 21 days post-antibiotic completion, as per intention-to-treat
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
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Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
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From 0-21 days after the end of the planned antibiotic therapy
|
Definite relapse within 28 days post-antibiotic completion, as per protocol
Time Frame: From 0-28 days after the end of the planned antibiotic therapy
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-28 days after the end of the planned antibiotic therapy
|
Definite relapse within 28 days post-antibiotic completion, as per intention-to-treat
Time Frame: From 0-28 days after the end of the planned antibiotic therapy
|
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-28 days after the end of the planned antibiotic therapy
|
Definite relapse within 28 days post-randomization, as per protocol
Time Frame: From 0-28 days after randomization
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-28 days after randomization
|
Definite relapse within 28 days post-randomization, as per Intention-to-treat
Time Frame: From 0-28 days after randomization
|
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-28 days after randomization
|
Definite relapse within 35 days post-randomization, as per protocol
Time Frame: From 0-35 days after randomization
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-35 days after randomization
|
Definite relapse within 35 days post-randomization, as per intention to treat
Time Frame: From 0-35 days after randomization
|
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode
|
From 0-35 days after randomization
|
Probable relapse within 21 days post-antibiotic completion, as per protocol
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
|
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-21 days after the end of the planned antibiotic therapy
|
Probable relapse within 21 days post-antibiotic completion, as per intention-to-treat
Time Frame: From 0-21 days after the end of the planned antibiotic therapy
|
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-21 days after the end of the planned antibiotic therapy
|
Probable relapse within 28 days post-antibiotic completion, as per protocol
Time Frame: From 0-28 days after the end of the planned antibiotic therapy
|
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after the end of the planned antibiotic therapy
|
Probable relapse within 28 days post-antibiotic completion, as per intention-to-treat
Time Frame: From 0-28 days after the end of the planned antibiotic therapy
|
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after the end of the planned antibiotic therapy
|
Probable relapse within 28 days post-randomization, as per protocol
Time Frame: From 0-28 days after randomization
|
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after randomization
|
Probable relapse within 28 days post-randomization, as per intention-to-treat
Time Frame: From 0-28 days after randomization
|
Among all randomized patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after randomization
|
Probable relapse within 35 days post-randomization, as per protocol
Time Frame: From 0-35 days after randomization
|
Among participants who adhered to study protocol Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-35 days after randomization
|
Probable relapse within 35 days post-randomization, as per intention-to-treat
Time Frame: From 0-35 days after randomization
|
Among all randomised patients Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-35 days after randomization
|
Definite relapse or probable relapse within 28 days post-randomization, as per protocol
Time Frame: From 0-28 days after randomization
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after randomization
|
Definite relapse or probable relapse within 28 days post-randomization, as per Intention-to-treat
Time Frame: From 0-28 days after randomization
|
Among all randomized patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-28 days after randomization
|
Definite relapse or probable relapse within 35 days post-randomization, as per protocol
Time Frame: From 0-35 days after randomization
|
Among participants who adhered to study protocol Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
|
From 0-35 days after randomization
|
Definite relapse or probable relapse within 35 days post-randomization, as per intention-to-treat
Time Frame: From 0-35 days after randomization
|
Among all randomised patients Definite relapse defined as: episode of blood-culture-positive relapse of neonatal sepsis caused by the same organism having the same antibiogram as the original episode Probable relapse: episode of illness without positive cultures adjudicated by a blinded adjudicator to be a relapse of the original episode of sepsis.
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From 0-35 days after randomization
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Secondary sepsis
Time Frame: From 0-35 days after randomization
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Sepsis due to bacterial organisms other than the original etiologic bacteria or with a different antibiogram or with a fungal organism
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From 0-35 days after randomization
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Adverse events
Time Frame: From 0-35 days after randomization
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Adverse events as per a list of adverse events, graded as per severity, and defined a priori
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From 0-35 days after randomization
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sourabh Dutta, Postgraduate Institute of Medical Education and Research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5/7/329/2009-RHN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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