T.E.A. Study: three-day ertapenem versus three-day Ampicillin-Sulbactam
Fausto Catena
0
Carlo Vallicelli
2
Luca Ansaloni
1
Massimo Sartelli
6
Salomone Di Saverio
5
Riccardo Schiavina
4
Eddi Pasqualini
2
Annalisa Amaduzzi
2
Federico Coccolini
1
Michele Cucchi
2
Daniel Lazzareschi
3
Gian Luca Baiocchi
7
Antonio D Pinna
2
0
Emergency Surgery Department, Parma University Hospital
,
Parma
,
Italy
1
General and Emergency Surgery Department, Ospedali Riuniti of Bergamo
,
Bergamo
,
Italy
2
General and Transplant Surgery Department, St. Orsola-Malpighi University Hospital
,
Bologna
,
Italy
3
Department of Integrative Biology, University of California
,
Berkeley
,
USA
4
Unit of Urology, St. Orsola-Malpighi University Hospital
,
Bologna
,
Italy
5
General and Trauma Surgery Department, Maggiore Hospital
,
Bologna
,
Italy
6
General Surgery Department, Hospital of Macerata
,
Macerata
,
Italy
7
Department of Medical and Surgical Sciences, Surgical Clinic, Brescia University
,
Brescia
,
Italy
Background: Intra-abdominal infections are one of the most common infections encountered by a general surgeon. However, despite this prevalence, standardized guidelines outlining the proper use of antibiotic therapy are poorly defined due to a lack of clinical trials investigating the ideal duration of antibiotic treatment. The aim of this study is to compare the efficacy and safety of a three-day treatment regimen of Ampicillin-Sulbactam to that of a three-day regimen of Ertapenem in patients with localized peritonitis ranging from mild to moderate severity. Results: 71 patients were treated with Ertapenem and 71 patients were treated with Ampicillin-Sulbactam. The two groups were comparable in terms of age and gender as well as the site of abdominal infection. Post-operative infection was identified in 12 patients: 10 with wound infections and 2 with intra-abdominal infections. In the Ertapenem group, 69 of the 71 patients (97%) were treated successfully, while the therapy failed in 2 cases (3%). Therapy failures were more frequent in the Unasyn group, amounting to 10 of 71 cases (p = 0.03). Conclusion: According to these preliminary findings, the authors conclude that a three-day Ertapenem treatment regimen is the most effective antibiotic therapy for patients with localized intra-abdominal infections ranging from mild to moderate severity. Trial registration: ClinicalTrials.gov: NCT00630513
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Methods: This study is a prospective, multi-center, randomized investigation performed in the Department of
General, Emergency, and Transplant Surgery of St. Orsola-Malpighi University Hospital in Bologna, Italy. Discrete data
were analyzed using the Chi-squared and Fisher exact tests. Differences between the two study groups were
considered statistically significant for p-values less than 0.05.
Background
Intra-abdominal infections are one of the most common
infections encountered by a general surgeon. These
infections are difficult to diagnose in their early stages and
effective treatment is equally challenging. Ertapenem and
Ampicillin-Sulbactam are both recommended as single
agent treatments to address localized peritonitis by the
SIS (Surgical Infections Society) and the IDSA (Infection
Diseases Society of America). 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 white blood cell count and return to gastrointestinal
function [1]. The ambiguity of these guidelines is the
result of a distinct lack of clinical trials investigating the
optimal duration of antibiotic therapy. Consequently, in
most trials involving antibiotic therapy, an arbitrarily fixed
period ranging from 5 to 14 days is used for all patients
with intra-abdominal infections, irrespective of the
severity of peritonitis. Most patients enrolled in trials involving
intra-abdominal infections present with mild peritonitis
and acute appendicitis [2]. Furthermore, most cases
feature localized infections or simple contamination. These
patients often receive superfluous antibiotic treatment. A
meta-analysis of twenty-eight studies investigating the
duration of antibiotic treatment in cases of advanced
pediatric appendicitis demonstrated that limiting the
duration of antibiotic treatment to three days was not
associated with a higher rate of abdominal abscesses or
wound infection [3]. A randomized study demonstrated
that shorter duration of Ertapenem therapy is as effective
as a 5-day treatment regimen in patients with mild to
moderate peritonitis [4]. Given that overuse of antibiotics
increases treatment costs, reduces clinical efficacy, and
spurs the emergence of antibiotic-resistant pathogens and
bacterial strains [5], a conservative shift in antibiotic
methodology is of utmost importance.
The aim of this study is to compare the efficacy and
safety of a three-day treatment regimen of
AmpicillinSulbactam to that of a three-day regimen of Ertapenem in
patients with localized peritonitis ranging fro (...truncated)