Moxifloxacin for the treatment of patients with complicated intra-abdominal infections (the AIDA Study).
This prospective, randomized, open, international, multicenter study of adults with complicated intra-abdominal infections (cIAI) compared the efficacy and safety of sequential intravenous (i.v.) to oral (p.o.) moxifloxacin 400 mg once daily, with that of i.v. ceftriaxone 2 g once daily, plus metronidazole 500 mg three times daily, followed by p.o. amoxicillin/clavulanate 625 mg three times daily. The primary efficacy variable was clinical cure at test of cure (TOC) (day 28-42 after study entry) in the per protocol (PP) population. Of 595 patients in the study, 511 patients were valid for PP analysis (246 moxifloxacin, 265 ceftriaxone/metronidazole). Sequential moxifloxacin was noninferior to the comparator regimen--clinical cure rates at TOC were 80.9% versus 82.3% (moxifloxacin versus ceftriaxone/metronidazole; 95% CI -8.9, 4.2%). The incidence of adverse events was comparable between the two treatment groups. Therefore, sequential moxifloxacin monotherapy is as effective and safe as combination therapy with i.v. ceftriaxone plus i.v. metronidazole followed by oral amoxicillin/clavulanate for the treatment of cIAI.
Department of Surgery, University Hospital, Magdeburg, Germany. guenter.weiss@klinikum-magdeburg.de
G
G
Weiss
P
P
Reimnitz
B
B
Hampel
E
E
Muehlhofer
H
H
Lippert
D018784:Abdominal Abscess / Q000188:drug therapy; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage / Q000009:adverse effects; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001064:Appendicitis / Q000150:complications / Q000188:drug therapy; D001372:Aza Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy* / Q000209:etiology; D002443:Ceftriaxone / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D024841:Fluoroquinolones; D005767:Gastrointestinal Diseases / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D007262:Infusions, Intravenous; D007416:Intestinal Perforation / Q000150:complications / Q000188:drug therapy; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000009:adverse effects; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D000077266:Moxifloxacin; D010538:Peritonitis / Q000188:drug therapy; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage* / Q000009:adverse effects
D000890:Anti-Infective Agents; D001372:Aza Compounds; D024841:Fluoroquinolones; D011804:Quinolines; D008795:Metronidazole; D019980:Amoxicillin-Potassium Clavulanate Combination; D002443:Ceftriaxone; D000077266:Moxifloxacin