CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 56 enrolled
Drug / intervention
Ertapenemdrug
Likely dose
Not stated in record
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Search/NCT01203046
NCT01203046Phase 3Completed

SP1 - Early Short-term Antibiotic Therapy in Penetrating Abdominal Trauma, 3 vs 7 Days

Silvia M. Pinango L.·interventional·Posted Sep 16, 2010·Updated Aug 10, 2012

In Brief

A Phase 3 clinical trial evaluating Ertapenem for SURGICAL SITE INFECTION. Completed, enrolled 56 participants.

Detailed Summary

Abdominal penetrating trauma represents a frequent cause of consult into emergency rooms in Venezuela. Accidents and violence at Hospital "Miguel Perez Carreño" along april 2009 were represented by gunshots and stabbing wounds which 8th. and 18th cause for medical attention respectively within a total of 76 cases. Likewise gunshot wounds reach the first cause of morbility into general surgery services with 21 cases and the stabbing wounds the 12th cause with 12 cases within the same period. Early therapy is defined as the antibiotic dose administrated within the first 12 hours after the trauma. Abdominal cavity contamination by micro-organism is not synonymous of stablished infection, the extension of contamination and intensity of reaction should be enough in order to allow the inflammatory focus developing. Abdominal cavity needs at least 12 - 24 hours of exposure to the infectious material to allow the stablishment of such infection. Origin and amount of contaminant material influence the size of inoculated bacteria and the speed that infection develops. There is not an absolute criteria to determine when intrabdominal contamination progress to an established infection. Surgeons decides the must adequated therapy according to clinical history, radiology tests and findings during surgery. Selected patients for early antibiotic therapy in penetrating abdominal trauma includes those with traumatic intestinal wounds with less than 12 hours of evolution and those with gastroduodenal wounds lesser than 24 hours as well. There are different antibiotics indicated for intrabdominal infections. Ertapenem is a low resistance carbapenem with a broad spectrum into microbial flora presenting in penetrating abdominal trauma. Its media life and blood therapeutic levels allows the use of an unique dose within the first 24 hours of trauma. This research protocol has been designed according to established patterns for clinical investigation and our goal is to achieve criteria in decision making about antibiotic administration in patients with penetrating abdominal trauma and evaluate the security of an Early short term antibiotic therapy with Ertapenem 3 days vs 7 days, decreasing hospital costs related to indiscriminate use of antibiotics.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 16, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2010
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 15.8 years ago

Interventions

Ertapenemdrug

Ertapenem 1 gr endovenous 3 or 7 days