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)
Federico Coccolini
0
Fausto Catena
0
Luca Ansaloni
2
Giorgio Ercolani
0
Salomone Di Saverio
1
Filippo Gazzotti
0
Daniel Lazzareschi
3
Antonio D Pinna
0
0
Unit of General, Emergency and Transplant Surgery, St. Orsola-Malpighi University Hospital
,
Bologna
,
Italy
1
Unit of Trauma and Emergency Surgery, Maggiore Hospital
,
Bologna
,
Italy
2
Unit of General Surgery, Ospedali Riuniti
,
Bergamo
,
Italy
3
Department of Integrative Biology, University of California
,
Berkeley
,
USA
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. Trial Registration: ClinicalTrials.gov: NCT00630513
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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 SantOrsola-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.
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 According to these guidelines, an antimicrobial
therapy for established infections should be continued
until resolution of clinical signs of infection occurs,
including normalization of temperature and WBC count
and return of gastrointestinal function [1].
Such ambiguity is primarily attributable to the lack of
clinical trials conducted on the topic of the optimal
duration of antibiotic therapy.
These vague guidelines have manifested themselves in
clinical practice; in most trials for antibiotic therapy, a fixed
period ranging from 5 to 14 days is used for all patients
presenting with community-acquired intra-abdominal
infection, irrespective of severity of the peritonitis.
It should be noted that secondary peritonitis
encompasses several different diseases and, as such, its severity
has been known vary significantly [2].
It has been demonstrated that most patients enrolled
in trials involving antibiotic treatment of IAI present
with a mild form of the acute illness, which in 35-55%
(and, in some studies, up to 70%) of cases is represented
by acute appendicitis [3]. It should also be noted that
many patients do not suffer from a fully developed and
widely spread infection but rather experience a localized
infection or simple contamination [4].
This means that many patients receive superfluous
and unnecessary antibiotic treatments. Many
non-random trials demonstrated that, by tailoring the duration
of the antibiotic therapy to the extent of the infection as
assessed during surgery, the same clinical results could
be obtained in all groups of treated patients without the
use of excessive antibiotic treatment regimens [5]. A
recent systematic meta-analysis of twenty-eight studies
on the duration of antibiotic therapy in cases of
advanced pediatric appendicitis demonstrated that
limiting the duration of antibiotic use to only 3 days was not
associated with higher rates of intra-abdominal abscesses
or wound infection [5].
In 2006, Basoli et al. demonstrated in a randomized
study that a shorter duration of Ertapenem is as
effective as a standard 5-day treatment regimen in patients
presenting with mild-moderate peritonitis, thereby
resulting in a significant reduction in the excessive use
of antibiotics. These results represent a much-needed
reassessment of antibiotic treatment and a conservative (...truncated)