A Randomized Clinical Trial of Moxalactam Alone versus Tobramycin plus Clindamycin in Abdominal Sepsis

Abstract
Patients (100) with intraabdominal infections were assigned randomly in double-blind fashion to receive either the combination of tobramycin plus clindamycin (TM/C) or moxalactam (MOX) alone. Fifty patients comprised each group, but 1 patient in each group died of infection before 48 h treatment. In the remaining 98 patients, the average age was 62 yr, initial serum albumin was 3.0 mg/dl, serum creatinine was 1.5 mg/dl and over half of the patients were nutritionally deficient by the prognostic nutritional index criteria. In .apprx. 1/2 of the patients, the source of infection was perforated colon or perforated appendix. There were no significant differences in demographic factors between these groups, except that those who were given TM/C were older, while those who were given MOX had a more serious long-term prognosis due to underlying disease. The average length of treatment was 11 days, and the average hospitalization time was 24 days. Clinical response to therapy was identical, since 74% of the TM/C patients and 76% of the MOX patients had satisfactory responses. Bacteria persisted at the site of infection in 63% of the TM/C patients and in 65% of the MOX patients, with the most common isolate being Staphylococcus epidermidis. Pseudomonas infections were the most difficult to cure in both groups. The 2 regimens differed only in side effects; TM/C was a more frequent (P < 0.05) cause of nephrotoxicity, and elevated prothrombin time/partial thromboplastin time (PT/PTT) was more frequently (P < 0.05) observed in MOX. All PT/PTT elevations responded to injections of vitamin K and no serious bleeding occurred. Choice between these regimens depends on the risk of renal vs. hematologic side efects, rather than efficacy.