Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study.

OBJECTIVE: The aim was to compare the efficacy and safety of two antibiotic regimens in patients with diabetic foot infections (DFIs). METHODS: Data of a subset of patients enrolled in the RELIEF trial with DFIs requiring surgery and antibiotics were evaluated retrospectively. DFI was diagnosed on the basis of the modified Wagner, University of Texas, and PEDIS classification systems. Patients were randomized to receive either intravenous/oral moxifloxacin (MXF, N = 110) 400 mg q.d. or intravenous piperacillin/tazobactam 4.0/0.5 g t.d.s. followed by oral amoxicillin/clavulanate 875/125 mg b.d. (PIP/TAZ-AMC, N = 96), for 7-21 days until the end of treatment (EOT). The primary endpoint was clinical cure rates in the per-protocol (PP) population at the test-of-cure visit (TOC, 14-28 days after EOT). RESULTS: There were no significant differences between the demographic characteristics of PP patients in either treatment group. At TOC, MXF and PIP/TAZ-AMC had similar efficacy in both the PP and intent-to-treat (ITT) populations: MXF: 76.4 % versus PIP/TAZ-AMC: 78.1 %; 95 % confidence interval (CI) -14.5 %, 9.0 % in the PP population; MXF: 69.9 % versus PIP/TAZ-AMC: 69.1 %; 95 % CI -12.4 %, 12.1 % in the ITT population. The overall bacteriological success rates were similar in both treatment groups (MXF: 71.7 % versus PIP/TAZ-AMC: 71.8 %; 95 % CI -16.9 %, 10.7 %). A similar proportion of patients (ITT population) experienced any adverse events in both treatment groups (MXF: 30.9 % versus PIP/TAZ-AMC: 31.8 %, respectively). Death occurred in three MXF-treated patients and one PIP/TAZ-AMC-treated patient; these were unrelated to the study drugs. CONCLUSION: Moxifloxacin has shown favorable safety and efficacy profiles in DFI patients and could be an alternative antibiotic therapy in the management of DFI. CLINICAL TRIAL: NCT00402727.

[Complicated skin and soft tissue infections]. / Komplizierte Haut- und Weichgewebsinfektionen.

Skin and soft tissue infections are common diseases. The spectrum ranges from slight furuncles to severe necrotizing soft tissue infections. Grampositive bacteria account for 70-80 % of cases as causative organisms. Diagnostics include rapid evaluation of locally limited or diffuse spreading extent of the disease. In complicated skin and soft tissue infections, surgical intervention with debridement and necronectomy is indicated. Necrotizing skin and soft tissue infections call for programmed redebridement. If systemic signs of inflammation are present (fever > 38 degrees C, leukocytosis, CRP elevation) or significant comorbidity exists, application of antibiotics is indicated. The prognosis in operatively treated patients is dependent on the time of surgical intervention.

[Diagnosis and therapy of sepsis. Guidelines of the German Sepsis Society Inc. and the German Interdisciplinary Society for Intensive and Emergency Medicine]. / Diagnose und Therapie der Sepsis. S2-Leitlinien der Deutschen Sepsis-Gesellschaft e.V. (DSG) und der Deutschen Interdisziplinären Vereinigung für Intensiv- und Notfallmedizin (DIVI).

A recent survey conducted by the publicly funded Competence Network Sepsis (SepNet) reveals that severe sepsis and/or septic shock occurs in 75,000 inhabitants (110 out of 100,000) and sepsis in 79,000 inhabitants (116 out of 100,000) in Germany annually. This illness is responsible for approximately 60,000 deaths and ranges as the third most frequent cause of death after acute myocardial infarction. Direct costs for the intensive care of patients with severe sepsis alone amount to approximately 1.77 billion euros, which means that about 30% of the budget in intensive care is used to treat severe sepsis. However, until now German guidelines for the diagnosis and therapy of severe sepsis did not exist. Therefore, the German Sepsis Society initiated the development of guidelines which are based on international recommendations by the International Sepsis Forum (ISF) and the Surviving Sepsis Campaign (SSC) and take into account the structure and organization of the German health care system. Priority was given to the following guideline topics: a) diagnosis, b) prevention, c) causative therapy, d) supportive therapy, e) adjunctive therapy. The guidelines development process was carefully planned and strictly adhered to the requirements of the Working Group of Scientific Medical Societies (AWMF).

Anastomotic leakage following low anterior resection: results of a standardized diagnostic and therapeutic approach.

BACKGROUND AND AIMS: This study analyzed the results of a standardized approach in anastomotic leakage following low anterior resection for rectal cancer without performance of a protective ileostomy during the primary operation. PATIENTS AND METHODS: The study included all 306 patients with rectal cancer electively undergoing low anterior resection with retroperitonealization of the anastomosis over 9 years. The diagnostic procedure for anastomotic leakage included serum laboratory investigations and abdominal CT together with contrast enema. Minor leakages, i.e., small leakages and pelvic abscess, were treated with rectoscopic lavage and/or CT-guided drainage of the abscess, respectively. Major leakage was defined as broad insufficiency with or without septicemia. Nonseptic patients were treated by ileostomy and rectoscopic treatment. In septic patients a revision of the anastomosis with loop ileostomy was performed. RESULTS: Anastomotic leakage was diagnosed in 30 patients (overall 9.8%; 12 major, 18 minor leakages). Common clinical signs were pelvic pain and fever. No patient developed a peritonitis. The most accurate diagnostic instrument was CT (96.7%). CONCLUSION: Retroperitonealization appears to prevent peritonitis in patients with anastomotic leakage following low anterior resection. A differential treatment leads to good results in terms of mortality and anorectal function.

[Perioperative prophylaxis in elective colorectal surgery]. / Untersuchungen zur perioperativen Prophylaxe in der elektiven colorectalen Chirurgie.

The effects of perioperative antibiotic prophylaxis in elective colon surgery was evaluated in a prospective study on 100 patients. Bowel cleansing was done by orthograde lavage. The patients were divided into 5 groups receiving equally cefotaxime 3 x 2 g, lamoxactam 3 x 2 g, cefmenoxime 3 x 1 g, mezlocillin 3 x 5 g an piperacillin 3 x 4 g. Mucosa biopsies of the resected colon were taken for aerobic and anaerobic cultures. Further mucosal serum probes were frozen immediately for determination of tissue and serum levels of the antibiotics. Our results show that bacterial growth of the colon mucosa was significantly reduced. Anaerobes were identified in only 8%. The tissue concentrations exceeded the MIC-levels of the identified bowel organisms many times over. The clinical infection rate was 4%. All administered antibiotics can be recommended without reservation.