The clinical effects and safety of a new antibacterial agent, AM-715, was evaluated in patients with acute infectious enteritis (bacillary dysentery, enteropathogenic E. coli enteritis, Campylobacter enteritis, Salmonella enteritis and other bacterial enteritis) and the corresponding carriers (174 subjects in total).
AM-715 was orally administered to the subjects at the daily dosage of 600 mg for 5 days except patients with acute Salmonella enteritis and the corresponding carriers administered for 7 days. The efficacy was analyzed in 176 patients and carriers on these subjectes.
Against 184 clinical strains from the subjects, the in vitro activity of AM-715 was compared with that of nalidixic acid (NA), pipemidic acid (PPA), ofloxacin (OFLX), enoxacin (ENX), ciprofloxacin (CPFX), kanamycin (KM), and fosfomycin (FOM).
The results of this study are summarized as follows:
1. Efficacy rate of AM-715 on clinical symptoms
The efficacy rate was 99.1% in 119 enteritic patients
2. Bacteriological efficacy rate of AM-715.
Each eradication rate was 98.8% in
Shigella spp., 100% in enteropathogenic
E. coli., 80% in
Campylobacter spp., 100% in
V. parahaemolyticus, 73.3% in
Salmonella spp. and 100% in other organisms.
3. Side effects of AM-715.
Five cases experienced side effects: soft stool in two cases, vomiting, diarrhoeaand skin rash in each one case as subjective symptoms. In clinical laboratory test, GPT elevated in seven cases, and GOT and GPT in four cases; and eosinocyte count increased in three case.
4. Antibacterial acivity of AM-715.
AM-715 showed stronger activity than NA, PPA, KM and FOM, and showed the same activity as that of PFLX, OFLX and ENX. AM-715 inhibited most of the strains at MICs of 0.05-0.1μg/ml against
Shigella spp. and
V. parahaemolyticus, at 0.1-0.2μg/ml against enteropathogenic
E. coli and
Salmonella spp. AM-715 inhibited all of the tested strains at 1.56μg/ml and 175 strains (95.1%) at as low as 0.39μg/ml.
Global efficacy was 95.5% in acute infectious enteritis. AM-715 was judged as a useful oral antibacterial for the treatment of these infections.
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