Clinical Experience with Intramuscular Sulbactam/Ampicillin in the Outpatient Treatment of Various Infections A Multicentre Trial

Summary

In a multicentre trial in Turkey, the efficacy and safety of sulbactam/ampicillin in the treatment of genitourinary tract, respiratory tract, ear, nose and throat, and skin and soft- tissue infections in a total of 532 patients were evaluated. Standard doses of sulbactam/ampicillin (0.25/0.5g) were administered intramuscularly bid for 4 to 15 days (mean 7.5 days).

The clinical efficacy of sulbactam/ampicillin ranged from 89.8 to 98.2% for each of the indication groups. Cure rates were 98.2% for ear, nose and throat infections; 96.1% for respiratory tract infections; 94.5% for skin and soft tissue; and 89.8% for urinary tract.

Overall antibacterial efficacy in the 517 patients for whom evaluation was possible was 91.3%. Persistence of pathogens was observed in 4.6%, and eradication with development of a superinfection in 4.1%.

In vitro superiority of sulbactam/ampicillin over ampicillin alone was demonstrated in 475 isolates where comparisons were made; the difference between the average inhibition zones of sulbactam/ampicillin and ampicillin was statistically significant (p < 0.001). 72.7% of 161 ampicillin-resistant isolates were sensitive and 19.3% were moderately sensitive to sulbactam/ampicillin.

Clinical cure was achieved in 88.3% of the 145 patients with infections due to ampicillin- resistant organisms, and an additional 7.6% improved. Bacteria were eradicated in 91.7%.

Sulbactam/ampicillin treatment was rated excellent in 87.5% of cases and good in 6.3%.

Adverse side effects tended to be predictable, mild and transient. Treatment was discontinued in only 4 patients because of adverse reactions.