Nosocomial Neonatal Sepsis
Conditions
Keywords
Coagulase negative staphylococcus, nosocomial neonatal sepsis, cefazolin, vancomycin, newborn
Brief summary
The objective is to evaluate the effectiveness of empiric treatment with cefazolin versus to vancomycin in newborn infants with presumptive clinical signs of hospital acquired bacterial sepsis probably caused by Coagulase-negative staphylococcus. The investigators hypothesized that newborn infants with the presumptive diagnosis of nosocomial sepsis who received cefazolin as empiric treatment would have a clinical outcome not inferior to that of those treated with vancomycin.
Interventions
DRUGCefazolin
DRUGVancomycin
DRUGAmikacin
Sponsors
Hospital Italiano de Buenos Aires
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Days to 4 Months
Healthy volunteers
No
Inclusion criteria
* Newborn infants older than three days of life with suspected bacterial sepsis and according to attending physicians, with an indication for initial treatment with vancomycin and at least one blood culture taken prior to receiving the antimicrobial treatment.
Exclusion criteria
* previous treatment with vancomycin during the week before, * infants referred from other hospitals and, upon admission, were being treated with antibiotics.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome of infants | Seven to ten days after starting antibiotics | Examination of each newborn infant by two of the investigators independently to establish whether the clinical outcome was adequate or inadequate. In order to achieve greater objectivity, the clinical examination was performed using the following criteria: Adequate: when the newborn infant had normal clinical parameters, a good general condition, appropriate tolerance to gastric feeding, normal temperature , negative blood and CSF cultures, and normalized results for the lab tests performed at the onset of the treatment. Inadequate: when one or more of the following were present: clinical course with persistence of any of the signs of sepsis, positive blood or CSF cultures after 72 hours from the onset of treatment, persistence of abnormal lab tests, and death by sepsis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of infants initially assigned to cefazolin group that were switched to vancomycin. | Within 72 hours of starting treatment | Patients with an inadequate 72 hour response to cefazolin were crossed over to receive vancomycin. The adjudication of response at 72 hours was delineated in a well-defined algorithm. To minimize bias, the final decision to switch treatments, initiated by the pediatrician in charge, required secondary review and agreement of another participating investigator as well as the attending NICU physician. |
Countries
Argentina
Outcome results
None listed