A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
NCT ID: NCT01825421
Last Updated: 2020-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-10-31
2016-06-30
Brief Summary
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Starting and continuing antibiotic therapy for blood culture-negative infections in the neonatal intensive care unit (NICU) is fairly common with numbers of such patients varying from 20%-90% of infants undergoing a sepsis evaluation in the NICU.
While blood culture results are the gold standard, there is usually a delay of up to 48-72h before the results are known. Hence, initiation and continuation of antibiotic treatment are usually based on clinical evaluation and blood count criteria which do not possess high specificity or sensitivity, and may be unreliable in the first few hours after birth or in the early stages of infection.
Since the investigators found that neutrophil CD64 (a type of protein found on the surface of a type of white blood cell that can be detected quickly in a very small amount of blood sample) has high accuracy for early detection of blood culture-proven infections in newborn babies, with extremely high negative predictive value (can identify babies definitively with no infection), the investigators will use this test to decide whether to stop or continue antibiotics in the NICU.
The investigators hypothesis is that neutrophil CD64 values can be safely used to discontinue antibiotics in newborns suspected of having infections.
The investigators aims are to utilize sequential measurements of CD64 values to stop antibiotics early in neonates being investigated for both early and late-onset infections in the NICU.
This is a prospective, randomized, controlled (RCT) trial. The study population will be derived from the sub-set of all newborn infants who have undergone investigations for presence of infection in the NICU.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Control (continue antibiotics) group
The antibiotics will be continued for at least another 24h i.e. for 48h, pending blood culture results at 48h, as per standard practice in the NICU.
No interventions assigned to this group
Study (discontinue antibiotics) group
The intervention is to discontinue antibiotics at 24h, and he/she will be kept under observation in the NICU for at least an additional 24h, pending blood culture results at 48h.
Intervention is to stop antibiotics at 24h .
Stoppage of antibiotics at 24h in the intervention arm, randomization based on neutrophil CD64 values.
Interventions
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Intervention is to stop antibiotics at 24h .
Stoppage of antibiotics at 24h in the intervention arm, randomization based on neutrophil CD64 values.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* The attending neonatologist has objections to the infant participating in the study
1 Hour
5 Months
ALL
No
Sponsors
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Yale University
OTHER
Responsible Party
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Locations
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Yale-New Haven Children's Hospital NICU
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1212011184
Identifier Type: -
Identifier Source: org_study_id
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