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).
Author(s): Coccolini F, Catena F, Ansaloni L, Ercolani G, Di Saverio S, Gazzotti F,
Lazzareschi D, Pinna AD.
Affiliation(s): Unit of General, Emergency and Transplant Surgery, St, Orsola-Malpighi University
Hospital, Bologna, Italy. fedecocco@iol.it
Publication date & source: 2011, BMC Gastroenterol. , 11:42
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/DESIGN: 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.
DISCUSSION: 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.
TRIAL REGISTRATION: ClinicalTrials.gov: NCT00630513.
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