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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Yale University
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01825421
First received: April 2, 2013
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention
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 Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 204
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825421

Locations
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    vineet.bhandari@yale.edu   
Principal Investigator: Vineet Bhandari, MD, DM         
Sponsors and Collaborators
Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01825421     History of Changes
Other Study ID Numbers: nCD64 ABX NICU - 01
Study First Received: April 2, 2013
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Infant
Infection
Newborn
Antibiotics
Neutrophil CD64
Blood Culture

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on August 18, 2014