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Trial record 12 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

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

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ClinicalTrials.gov Identifier: NCT01203046
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : July 26, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Silvia M. Pinango L., Pinango, Silvia M. L., M.D.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition SURGICAL SITE INFECTION
Intervention Drug: Ertapenem
Enrollment 56
Recruitment Details The data was collected between December 2010 and November 2011 including patients with penetrating abdominal trauma admitted at Dr. Miguel Perez Carreño Hospital emergency room.
Pre-assignment Details We were behind schedule to start the trial waiting for institutional approve.
Arm/Group Title GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY
Hide Arm/Group Description

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group A will be treated with Ertapenem during the following four days.

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group B will be treated with placebo during the following four days.

Period Title: Overall Study
Started 28 28
Completed 28 28
Not Completed 0 0
Arm/Group Title GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY Total
Hide Arm/Group Description

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group A will be treated with Ertapenem during the following four days.

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group B will be treated with placebo during the following four days.

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
<=18 years
7
  25.0%
3
  10.7%
10
  17.9%
Between 18 and 65 years
21
  75.0%
25
  89.3%
46
  82.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
26.2857  (9.5450) 28.5000  (9.8639) 27.3929  (9.6929)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
2
   7.1%
3
  10.7%
5
   8.9%
Male
26
  92.9%
25
  89.3%
51
  91.1%
Type of trauma   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
GSW 24 22 46
SW 4 6 10
[1]
Measure Description: To describe the mechanism of penetrating abdominal trauma: Gun shot wound (GSW) or Stab wound (SW)
1.Primary Outcome
Title Surgical Site Infection
Hide Description The patients were evaluated up to 10 days with close observation of surgical site. We concluded as surgical site infection when inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption was observed.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with inflammatory signs, purulent discharge, intestinal liquid and aponeurosis disruption observed at surgical site were included.
Arm/Group Title GROUP A: 7 DAYS THERAPY GROUP B - 3 DAYS THERAPY
Hide Arm/Group Description:

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group A will be treated with Ertapenem during the following four days.

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group B will be treated with placebo during the following four days.

Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: participants
6 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GROUP A: 7 DAYS THERAPY, GROUP B - 3 DAYS THERAPY
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments It was used for the calculation of statistical power an author of 5% level, it was felt that the difference between the minimum value of non inferiority does not exceed 10%.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.65
Confidence Interval (2-Sided) 95%
0.35 to 19.83
Estimation Comments [Not Specified]
2.Primary Outcome
Title Other Complications
Hide Description Patients with complications different to surgical site infection.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who presented any complication different of surgical site infection after surgery
Arm/Group Title GROUP A - 7 DAYS THERAPY GROUP B - 3 DAYS THERAPY
Hide Arm/Group Description:
Patients with 7 days therapy
Patients with 3 days therapy
Overall Number of Participants Analyzed 28 28
Measure Type: Number
Unit of Measure: participants
8 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GROUP A - 7 DAYS THERAPY, GROUP B - 3 DAYS THERAPY
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Consider a 5% confidence level, the power of assigned contrast was 80% to detect a difference minima of at least 10% of equivalence between the analyzed groups.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.21 to 6.51
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY
Hide Arm/Group Description

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group A will be treated with Ertapenem during the following four days.

Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.

Group B will be treated with placebo during the following four days.

All-Cause Mortality
GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GROUP A: 7 DAYS ANTIBIOTIC THERAPY GROUP B: 3 DAYS ANTIBIOTIC THERAPY
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/28 (0.00%) 
Presented limitations because patients with penetrating abdominal trauma usually had associated bone fractures or haemodynamic instability.Identifying other predisposing factors is not reached since the sample size was restricted to only two groups.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Silvia M. Pinango L.
Organization: Dr. Silvia M. Pinango L
Phone: +584169267988
EMail: pinangosilvia@yahoo.com
Publications:
Layout table for additonal information
Responsible Party: Silvia M. Pinango L., Pinango, Silvia M. L., M.D.
ClinicalTrials.gov Identifier: NCT01203046     History of Changes
Other Study ID Numbers: SP 01
First Submitted: September 14, 2010
First Posted: September 16, 2010
Results First Submitted: February 10, 2012
Results First Posted: July 26, 2012
Last Update Posted: August 10, 2012