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Randomized trial of imipenem/cilastatin versus gentamicin and clindamycin in mixed flora infections
Abstract:
Results of a randomized trial comparing imipenem/cilastatin versus the combination of gentamicin plus clindamycin for mixed flora surgical sepsis are reported herein. Seventy-four patients were evaluable, 50 of whom had intra-abdominal sepsis. No imipenem-resistant initially infecting isolates were encountered. When outcome was evaluated on the basis of severity scoring (APACHE II), no difference in mortality was noted. However, therapy in two patients with Pseudomonas emerging from a polymicrobial flora failed with gentamicin, whereas no Pseudomonas failures were noted with imipenem/cilastatin. The major difference noted was in toxicity. There was a 20 percent incidence of nephrotoxicity in gentamicin-treated patients despite serum level monitoring and multiple dose adjustments. The degree of efficacy and the relative tolerability of imipenem/cilastatin in seriously ill surgical patients is demonstrated.
Insights
Imipenem/cilastatin showed better efficacy and tolerability than gentamicin plus clindamycin for surgical sepsis. This study highlights imipenem/cilastatin as a potentially safer option for treating severe intra-abdominal infections.
Area of Science:
- Infectious Diseases
- Surgical Infections
- Pharmacology
Background:
- Surgical sepsis, particularly intra-abdominal infections with mixed flora, presents significant treatment challenges.
- Empirical antibiotic therapy is crucial, but resistance and toxicity remain concerns.
- Comparing broad-spectrum agents is essential for optimizing patient outcomes.
Purpose of the Study:
- To compare the efficacy and toxicity of imipenem/cilastatin versus gentamicin plus clindamycin in patients with mixed flora surgical sepsis.
- To evaluate the emergence of Pseudomonas and the incidence of nephrotoxicity in both treatment arms.
Main Methods:
- A randomized trial involving 74 evaluable patients with surgical sepsis, 50 with intra-abdominal infections.
- Patients were treated with either imipenem/cilastatin or gentamicin plus clindamycin.
- Outcomes assessed included mortality (APACHE II scoring), pathogen emergence, and adverse events, specifically nephrotoxicity.
Main Results:
- No imipenem resistance was observed in initial isolates.
- Mortality rates were similar between the two groups based on APACHE II scores.
- Gentamicin therapy failed in two cases due to emerging Pseudomonas, while imipenem/cilastatin showed no such failures.
- Nephrotoxicity occurred in 20% of patients receiving gentamicin, despite monitoring and dose adjustments.
Conclusions:
- Imipenem/cilastatin demonstrated superior tolerability and efficacy compared to gentamicin plus clindamycin in this surgical sepsis cohort.
- Imipenem/cilastatin may be a preferred treatment option for seriously ill surgical patients, especially those with potential for Pseudomonas emergence.
- Reduced nephrotoxicity associated with imipenem/cilastatin offers a significant clinical advantage.