netilmicin and Appendicitis

In a multicentre trial we compared the clinical efficacy of amoxicillin/clavulanate used as a single-agent therapy with that of the three-agent combination usually prescribed in the post-operative period for appendicular peritonitis in children. Only bacteriologically documented peritoneal infections were included. Sixty-four patients were randomly distributed between two groups: Group A (29 cases) treated with amoxicillin/clavulanate, first administered iv (100 mg/kg/d), followed by conversion to the oral route (50 mg/kg/d) once the patient had been afebrile for 48 hours; Group B (35 cases) first treated by the iv route with benzylpenicillin (100,000 IU/kg/d) plus netilmicin (5 mg/kg/d) plus metronidazole (30 mg/kg/d), followed by conversion to the oral route for metronidazole (30 mg/kg/d). In both groups, the total duration of parenteral and oral treatment was not less than 5 days. One hundred and seventy nine bacterial strains were recovered from peritoneal fluid samples obtained during surgery; 86% of these were sensitive to amoxicillin/clavulanate. Clinical efficacy, assessed on the basis of time until return to normal temperature and gut transit and duration of hospitalization, was identical in both groups, with follow-up monitoring on day 30 showing recovery in all cases. Cure was obtained without any problems of infection in 25/29 patients in group A and in 34/35 patients in group B (non significant difference). Tolerance was excellent and identical in the two groups with the exception of three cases of thrombophlebitis which occurred in group B. The results of this study suggest that amoxicillin/clavulanate may be useful as single-agent therapy as a first-line curative treatment for appendicular peritonitis in children.

Topics: Adolescent; Amoxicillin; Appendicitis; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Intestinal Perforation; Male; Metronidazole; Netilmicin; Penicillin G; Rupture, Spontaneous; Time Factors

This multicentric, randomized, double-blind trial compared the efficacy and safety of netilmicin, 4.5 mg/kg od and 1.5 mg/kg tid, in patients with intra-abdominal infections. Of 114 patients enrolled, 57 patients (mean age 40.3 years) in the od group and 55 (mean age 36.8 years) in the tid group were evaluated for efficacy; 58 and 56 patients in corresponding groups were evaluated for safety. Among those evaluated for efficacy were 12 od-treated and 11 tid-treated patients with documented septicaemia, and 32 and 30 patients of respective groups with polymicrobial infections. Initially, 86 and 81 netilmicin-susceptible causative microorganisms were isolated in corresponding groups. Of these pathogens, 55% in the od group and 62% in the tid group were Escherichia coli. Daily dosage of netilmicin ranged from 3.70 to 4.71 mg/kg (mean 4.50) for the od group and from 3.06 to 4.76 mg/kg (mean 4.46) for the tid group. Duration of netilmicin therapy ranged from six to 13 days (mean 8.7 days) for od-treated patients and from seven to 16 days (mean 8.8 days) for tid-treated patients. Concomitant metronidazole was administered to 41 patients of the od group and 34 of the tid group; one patient in the tid group received clindamycin. Clinical and bacteriological responses were assessed, and peak and trough serum netilmicin levels were measured periodically, during therapy. Laboratory tests, including determinations of serum creatinine and blood urea nitrogen values, were performed throughout the trial. A clinical cure was achieved in 57/57 od-treated patients and 54/55 tid-treated patients; treatment failed in one tid-treated patient (1/55). In od and tid groups, 86/86 and 80/81 netilmicin-susceptible pathogens initially isolated were considered to be eliminated, respectively; one isolate (Esch. coli) persisted in the tid group. Mean peak serum netilmicin concentration in the od group was approximately two-fold greater than that in the tid group; mean trough serum netilmicin concentrations were similar for the two groups. Adverse reactions were limited to mild pain at the site of netilmicin administration in several patients in each treatment group. Netilmicin od and tid (alone or in combination with metronidazole) were similarly efficacious in the treatment of patients with appendicitis and other intra-abdominal infections caused by netilmicin-susceptible pathogens. Both dosage regimens of netilmicin were safe and well tolerated.

Topics: Abdomen; Adolescent; Adult; Aged; Aged, 80 and over; Appendicitis; Bacterial Infections; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Netilmicin; Random Allocation

This multicentre trial compared the clinical efficacy of amoxycillin/clavulanate used as a single-agent therapy with that of the three-agent combination usually prescribed in the post-operative period for appendicular peritonitis in children. Only bacteriologically documented peritoneal infections were included. Sixty-four patients were randomly distributed between two groups: Group A (29 cases) treated with amoxycillin/clavulanate, first administered iv (100 mg/kg/day) followed by conversion to the oral route (50 mg/kg/day) once the patient had been afebrile for 48 h; Group B (35 cases) first treated by the iv route with benzylpenicillin (100,000 IU/kg/day) plus netilmicin (5 mg/kg/day) plus metronidazole (30 mg/kg/day) followed by conversion to the oral route for metronidazole (30 mg/kg/day). In both groups, the total duration of parenteral and oral treatment was not less than five days. A total of 180 bacterial strains were recovered from peritoneal fluid samples obtained during surgery; 86% of these were sensitive to amoxycillin/clavulanate. Clinical efficacy, assessed on the basis of time until return to normal temperature and gut transit and duration of hospitalization, was identical in both groups, with follow-up monitoring on day 30 showing recovery in all cases. Cure was obtained without any problems of infection in 25/29 patients in group A and in 34/35 patients in group B (non-significant difference). Tolerance was excellent and identical in the two groups with the exception of three cases of thrombophlebitis which occurred in group B. The results of this study suggest that amoxycillin/clavulanate may be useful as single-agent therapy as a first-line curative treatment for appendicular peritonitis in children.

Topics: Amoxicillin; Appendicitis; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Metronidazole; Netilmicin; Penicillin G; Peritonitis; Postoperative Period; Randomized Controlled Trials as Topic

The safety and efficacy of a single daily dose of netilmicin plus metronidazole after appendicectomy for gangrenous and perforated appendicitis was compared with the traditional thrice daily dosage. Twenty patients were enrolled in each group. The antibiotics were given intramuscularly for seven days after operation. Eradication of infection was observed in all patients and the postoperative wound sepsis was the same for each group. A significantly higher peak serum netilmicin level was achieved in the group receiving a single daily dose but nephrotoxicity was not observed. We concluded that the single daily dose of netilmicin was well tolerated and was as efficacious in this small series as the thrice daily regimen. The single-dose regimen has the advantage of simplicity and potentially increased bactericidal activity.

Topics: Adolescent; Adult; Aged; Appendicitis; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Metronidazole; Middle Aged; Netilmicin; Random Allocation