M. Extermann et al., INITIAL TREATMENT OF SEPSIS IN NON-NEUTROPENIC PATIENTS - CEFTAZIDIMEALONE VERSUS BEST GUESS COMBINED ANTIBIOTIC-THERAPY, Chemotherapy, 41(4), 1995, pp. 306-315
We conducted a prospective, randomized, multicentric study in communit
y hospitals. Patients with clinical sepsis, rectal temperature greater
than or equal to 38 degrees C and pulse rate greater than or equal to
100 bpm were randomized to receive ceftazidime (group CAZ) or a combi
nation of antibiotics freely chosen by the clinician following his 'be
st guess' (group COMB). On specified grounds, the clinician could also
treat patients in an open group with a free combination of antibiotic
s (group OPEN). The severity of disease at study admission was assesse
d by a clinical estimation and an Apache II score. There were 128 pati
ents included: 56 randomized in group CAZ, 50 in group COMB, and 22 in
the OPEN group. Ninety-one patients were evaluable: 41 in group CAZ,
30 in group COMB, 20 in OPEN group. At the end of the period of empiri
cal treatment (48-72 h), the clinical success rates (improvement of st
atus) were 93, 93 and 75% (p for group OPEN vs. groups CAZ or COMB: 0.
10). The bacteriological success rates (sterile blood cultures) were 9
1, 88 and 80% (p not significant). The mean Apache II score was 16.7 a
nd the score correlated significantly with outcome, as did clinical ev
aluation. In conclusion, ceftazidime alone was a safe antibiotic thera
py in this study and we could not demonstrate a superiority of a combi
ned antibiotic therapy chosen by the clinician following his 'best gue
ss' over ceftazidime.