A multicenter, open, randomized, and comparative study was carried out
with 67 general practitioners and pneumologists, in two groups of pat
ients suffering from acute bacterial exacerbation of chronic obstructi
ve pulmonary disease (COPD), in order to compare the clinical efficacy
and safety of cefadroxil and co-amoxiclav. Two hundred and forty four
patients (mean age 62) were enrolled in this study; 126 were treated
with cefadroxil and 118 treated with co-amoxiclav. After checking the
eligibility criteria, obtaining written consent, and randomizing, the
patients were given either cefadroxil at 2 g/day or co-amoxiclav at 1.
5 g/day, during 10 days. At moment of the inclusion, no significant di
fference was observed between the two groups except for two criteria:
sex (p = 0.05), and concomitant physiotherapy treatment (p = 0.049). A
complementary analysis excluded any effect of these two factors on ef
ficacy. COPD main etiology of was chronic bronchitis in 70.1 % of pati
ents. The Anthonisen score was equal to 1 in 63.5 % of patients, 2 in
34 % of patients. The main item assessed was the outcome, whether succ
essful or not, according to the clinical signs at D1. Successful clini
cal outcome was comparable for both groups (intent-to-treat analysis)
with 94.4 % for cefadroxil and 95.8 % for co-amoxiclav. No significant
difference was observed between the two study groups for the delay fo
r improvement of clinical signs (mean delay for improvement: 4.5 days)
. Global clinical safety was considered to be good and comparable in b
oth study groups. But diarrheas was significantly more important in pa
tients treated with co-amoxiclav (p = 0.001). The clinical efficacy an
d safety of cefadroxil, observed in this study, demonstrate that it is
a choice antibiotic for empiric treatment of COPD superinfections in
general practice and that it follows the Opposable Medical Guidelines.