@article{3045349,
    title = "A COMPARISON OF CEFTAZIDIME AND AMINOGLYCOSIDE BASED REGIMENS AS
EMPIRICAL-TREATMENT IN 1316 CASES OF SUSPECTED SEPSIS IN THE NEWBORN",
    author = "DELOUVOIS, J and DAGAN, R and TESSIN, I and HARVEY, D and TROLLFORS, B and and THIRINGER, K and VALIDO, A and COSTA, A and BAUMER, H and BRINES, J and and DIEZ and BENIC, L and BADOUAL, J and CORBEEL, L and ROOS, R and and KAFETZISA, D and PEDERSEN, S and COLUMBO, A",
    journal = "European Journal of Pediatrics",
    year = "1992",
    volume = "151",
    number = "12",
    pages = "876-884",
    publisher = "Springer-Verlag",
    issn = "0340-6199, 1432-1076",
    doi = "10.1007/BF01954122",
    keywords = "INFECTIOUS DISEASES; NEONATAL INFECTIONS; CEPHALOSPORINS; CEFTAZIDIME;
AMINOGLYCOSIDES",
    abstract = "We report a prospective, non-blind, randomised, multicentre, parallel
group, multinational investigation to compare ceftazidime to
aminoglycoside based regimens as empirical treatment in 1316 cases of
suspected sepsis in the newborn. In each of the 15 study centres either
ceftazidime alone (CAZ) or ceftazidime + ampicillin (CAZ+AMP) was
compared to an aminoglyocoside/ampicillin combination (AG+AMP). In all
cases treatment was based on “an intention to treat”. Bacteria
considered to be pathogenic were isolated from 176/1316 (13.4%)
patients. The incidence of proven infection varied from 39% in a
Yugoslav centre to 6% in a British centre; a further 489/1316 (37.1%)
patients fulfilled the criteria for clinically suspected sepsis. A total
of 210 bacterial isolates from 197 infection sites in 176 patients were
considered to be clinically significant. The cure rate for evaluable
patients with proven infection who were treated with CAZ+AMP (97%,
30/31) was significantly higher than that for the corresponding patients
treated with AG+AMP (66%, 26/39), (P < 0. 002). The difference in cure
rate between CAZ monotherapy (79%, 34/43) and AG+AMP (86%, 32/37) was
not significant. Treatment failed in 28/150 (18.7%) evaluable patients.
There were significantly fewer failures (P < 0.001) with CAZ+AMP than
with AG+AMP therapy. There were 55 staphylococcal infections. Treatment
was successful in 16/19 evaluable patients treated with CAZ or CAZ+AMP
and in 16/29 evaluable patients treated with AG+AMP. None of the study
centres encountered problems with ceftazidime resistant bacteria. The
cure rate for patients with only clinical and radiological evidence of
sepsis was greater than 94% in all treatment groups. Of the study
population 65 (4.9%) died, 15 deaths were attributed to infection,
pathogenic bacteria were only isolated from 10. The mortality rate for
infected babies was 5.7% compared to 4.8% for those without confirmed
infection. All the deaths associated with infection were due to
Gram-positive bacteria. This study suggests that the practice of
continuing antibiotic therapy once pretreatment cultures are known to be
negative should be seriously reconsidered. It is concluded that CAZ+AMP
is superior to either AG+AMP or ceftazidime monotherapy for the
treatment of infection in the newborn. Further studies are required to
confirm these observations in neonates with proven infection."
}