Clinical trial NCT01825421: A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
Official title: A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neonatal Early-onset Sepsis
Neonatal Late-onset Sepsis
Keywords: Infant
Infection
Newborn
Antibiotics
Neutrophil CD64
Blood Culture
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At 48h after initiation of antibiotics.
Secondary outcomes:
measure: Change in the Neutrophil CD64 Index value in neonates with/without exposure to antibiotics from 24h to 48h.
timeFrame: At 48h after initiation of antibiotics.
Other outcomes:
measure: Number of positive blood cultures in neonates from 24h to 48h with/without exposure to antibiotics.
timeFrame: At 48h after initiation of antibiotics.
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital NICU
state: Connecticut
Study officials:
References: