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[A clinical evaluation of MK-0787/MK-0791 for long-term administration in urological infections]
Abstract:
MK-0787 (Imipenem)/MK-0791 (Cilastatin sodium), a new compound of Thienamycin, was administered in treatment of 35 patients (36 cases) with chronic complicated UTI or for prevention of serious infections with much complicated factors. The patients were principally treated at a daily dose of 1 g for over 10 days. The efficacy rate of 26 patients who were evaluable in the early phase (4-7 days) was 88.5%, while it became up to 92.3% in the final phase judgment. As for clinical usefulness, the result was obtained to be as high as that of the clinical efficacy. In bacteriological study, 35 strains were clinically isolated including 7 strains of P. aeruginosa from UTI. All the strains disappeared with an eradication rate of 100% after treatment. Strains appearing after Imipenem/Cilastatin sodium treatment mainly consisted of fungi. Usefulness judgements tended to be greater in the final phase than in the early phase. As for side effects, vomiting was recorded in one case, in which the administration was discontinued. In laboratory findings there were 3 cases with elevated GPT, 2 cases with elevated GOT, one case with elevated gamma-GTP, one with thrombocytopenia, and one with eosinophilia each, but these abnormal values were slight and transient. In summary our clinical study showed that Imipenem/Cilastatin sodium was a very effective antibiotic in treatment on moderate or serious UTI or preventive use for infections in compromised hosts. Considering the features of this agent, it might be more effective and useful for clinical use in treatment on polymicrobial infections including stubborn organisms than any other antimicrobial compounds. Furthermore, it was safe and well tolerable in a long term treatment.
Insights
Imipenem/Cilastatin sodium demonstrated high efficacy in treating complicated urinary tract infections (UTI) and preventing serious infections. This antibiotic showed excellent bacterial eradication and was well-tolerated, even in long-term use.
Area of Science:
- Infectious Diseases
- Pharmacology
- Urology
Background:
- Chronic complicated urinary tract infections (UTI) and serious infections in compromised hosts pose significant treatment challenges.
- The need for effective antimicrobial agents with broad-spectrum activity and favorable safety profiles is critical.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of Imipenem/Cilastatin sodium in treating complicated UTI and preventing serious infections.
- To assess the bacteriological eradication rates and identify any emerging resistant strains or opportunistic infections.
Main Methods:
- A clinical study involving 35 patients (36 cases) with chronic complicated UTI or at high risk for serious infections.
- Patients received a daily dose of 1g of Imipenem/Cilastatin sodium for over 10 days.
- Efficacy was assessed in early (4-7 days) and final phases, alongside bacteriological analysis and monitoring for adverse events.
Main Results:
- An overall efficacy rate of 92.3% was observed, with clinical usefulness mirroring efficacy.
- 100% eradication rate for all 35 isolated bacterial strains, including 7 strains of P. aeruginosa.
- Minimal and transient side effects were noted, including mild gastrointestinal upset and slight laboratory abnormalities.
Conclusions:
- Imipenem/Cilastatin sodium is a highly effective and safe antibiotic for treating moderate to severe UTI and for infection prevention in compromised hosts.
- Its broad-spectrum activity makes it particularly useful for polymicrobial infections, including those with resistant organisms.
- The agent is well-tolerated for long-term treatment, offering a valuable therapeutic option.