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A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01825421
Recruitment Status : Withdrawn (No funding obtained)
First Posted : April 5, 2013
Last Update Posted : July 15, 2015
Information provided by (Responsible Party):
Yale University

Brief Summary:

Unnecessary and prolonged antibiotic therapy in newborn babies can have serious consequences including development of necrotizing enterocolitis (a serious, potentially life-threatening gastrointestinal illness in premature babies), late-onset infections, resistance to antibiotics, increased length of hospital stay, and death.

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.

Condition or disease Intervention/treatment Phase
Neonatal Early-onset Sepsis Neonatal Late-onset Sepsis Other: Intervention is to stop antibiotics at 24h . Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
Study Start Date : October 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
No Intervention: 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.
Active Comparator: 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.
Other: Intervention is to stop antibiotics at 24h .
Stoppage of antibiotics at 24h in the intervention arm, randomization based on neutrophil CD64 values.

Primary Outcome Measures :
  1. Number of infants with early-onset sepsis (EOS) and late-onset sepsis (LOS) randomized to either stopping or continuing antibiotics at 24h, based on the neutrophil CD64 measurement [ Time Frame: At 48h after initiation of antibiotics. ]

Secondary Outcome Measures :
  1. Change in the Neutrophil CD64 Index value in neonates with/without exposure to antibiotics from 24h to 48h. [ Time Frame: At 48h after initiation of antibiotics. ]

Other Outcome Measures:
  1. Number of positive blood cultures in neonates from 24h to 48h with/without exposure to antibiotics. [ Time Frame: At 48h after initiation of antibiotics. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants undergoing a sepsis evaluation in the NICU

Exclusion Criteria:

  • They have a major life-threatening congenital malformation
  • The attending neonatologist has objections to the infant participating in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01825421

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United States, Connecticut
Yale-New Haven Children's Hospital NICU
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University

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Responsible Party: Yale University Identifier: NCT01825421     History of Changes
Other Study ID Numbers: nCD64 ABX NICU - 01
First Posted: April 5, 2013    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by Yale University:
Neutrophil CD64
Blood Culture
Additional relevant MeSH terms:
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Neonatal Sepsis
Systemic Inflammatory Response Syndrome
Pathologic Processes
Infant, Newborn, Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents