A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
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.
Neonatal Early-onset Sepsis
Neonatal Late-onset Sepsis
Other: Stoppage of antibiotics at 24h vs. continuing antibiotics for 48h, randomization based on neutrophil CD64 values.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64|
- 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. ] [ Designated as safety issue: Yes ]
- 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. ] [ Designated as safety issue: No ]
- Number of positive blood cultures in neonates from 24h to 48h with/without exposure to antibiotics. [ Time Frame: At 48h after initiation of antibiotics. ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
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 antibiotics will be discontinued 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: Stoppage of antibiotics at 24h vs. continuing antibiotics for 48h, randomization based on neutrophil CD64 values.|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01825421
|United States, Connecticut|
|Yale-New Haven Children's Hospital NICU||Not yet recruiting|
|New Haven, Connecticut, United States, 06520|
|Contact: Vineet Bhandari, MD, DM 203-785-2613 email@example.com|
|Principal Investigator: Vineet Bhandari, MD, DM|