title: A prospective, multi centre, randomized clinical study to compare the efficacy and safety of Ertapenem 3 days versus Ampicillin-Sulbactam 3 days in the treatment of localized community acquired intra-abdominal infection. (T.E.A. Study: Three days Ertapenem vs three days Ampicillin-sulbactam).
abstract: BACKGROUND
  The recommendations outlined in the latest guidelines published by the Surgical Infection Society (SIS) and the Infectious Disease Society of America (IDSA) regarding the proper duration of antibiotic therapy in patients with intra-abdominal infections are limited and non-specific. This ambiguity is due mainly to the lack of clinical trials on the topic of optimal duration of therapy. It is well known that the overuse of antibiotics has several important consequences such as increased treatment costs, reduced clinical efficacy, and above all, the increased emergence of antibiotic-resistant pathogens. Ampicillin-Sulbactam is a commonly used "first line" antibiotic for intra-abdominal infections. Ertapenem and Ampicillin-sulbactam are recommended as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines.
  
  
  METHODS
  This study is a prospective multi-center randomized investigation. The study will be performed in the Departments of General, Emergency, and Transplant Surgery of Sant'Orsola-Malpighi University Hospital in Bologna, Italy, in the General Surgery Department of the Ospedali Riuniti of Bergamo, Italy, and in the Trauma and Emergency Surgery Department of Maggiore Hospital in Bologna, Italy, and will be conducted by all surgeons willing to participate in the study. The inclusion period of the study will take approximately two years before the planned number of 142 enrolled patients is reached.
  
  
  CONCLUSIONS
  Ertapenem and Ampicillin-sulbactam are recommended both as primary treatment agents for localized peritonitis by both the SIS and IDSA guidelines. As one of the discussed topic is the optimal duration of the antibiotic therapy and this ambiguity is due mainly to the lack of clinical trials on the topic, the present study aims for obtain precise data.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00630513.
authors.affiliation: Unit of General, Emergency and Transplant Surgery, St, Orsola-Malpighi University Hospital, Bologna, Italy. fedecocco@iol.it
authors.forename: Federico
authors.initials: F
authors.lastname: Coccolini
authors.forename: Fausto
authors.initials: F
authors.lastname: Catena
authors.forename: Luca
authors.initials: L
authors.lastname: Ansaloni
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ercolani
authors.forename: Salomone
authors.initials: S
authors.lastname: Di Saverio
authors.forename: Filippo
authors.initials: F
authors.lastname: Gazzotti
authors.forename: Daniel
authors.initials: D
authors.lastname: Lazzareschi
authors.forename: Antonio D
authors.initials: AD
authors.lastname: Pinna
mesh_terms: D000005:Abdomen / Q000382:microbiology; D000328:Adult; D000667:Ampicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001424:Bacterial Infections / Q000188:drug therapy*; D002985:Clinical Protocols; D017714:Community-Acquired Infections / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D000077727:Ertapenem; D006801:Humans; D010538:Peritonitis / Q000188:drug therapy / Q000382:microbiology; D013407:Sulbactam / Q000008:administration & dosage* / Q000009:adverse effects; D047090:beta-Lactams / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000900:Anti-Bacterial Agents; D047090:beta-Lactams; D000667:Ampicillin; D000077727:Ertapenem; D013407:Sulbactam