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Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections

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ClinicalTrials.gov Identifier: NCT00929643
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : August 6, 2012
Last Update Posted : August 10, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Observational
Study Design Time Perspective: Prospective
Condition Complicated Intra-Abdominal Infection
Intervention Other: no intervention
Enrollment 203
Recruitment Details  
Pre-assignment Details Observational, epidemiological, noninterventional study.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Period Title: Overall Study
Started 203
Completed 201
Not Completed 2
Reason Not Completed
Protocol Violation             2
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Baseline Participants 201
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 201 participants
57.4  (19.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 201 participants
Female
65
  32.3%
Male
136
  67.7%
1.Primary Outcome
Title Duration of Hospitalization
Hide Description Overall health care resource utilization was analyzed using mean duration of hospitalization.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: Days
14.1  (12.7)
2.Primary Outcome
Title Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Hide Description [Not Specified]
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: Percentage of participants
Metronidazole 59.2
b-Lactamase Inhibitors (BLI) 38.3
Cephalosporines (2nd generation) 30.3
Quinolones 16.9
Aminoglycocides 12.4
Carbapenems 8.5
Glycopeptides 8.0
Glycycyclines 5.0
Antifungals 4.0
Cephalosporines (3rd generation) 4.0
Lipopeptides/oxazolidinones 2.0
Clindamycin 1.5
Beta lactams 0.5
Cephalosporines (4th generation) 0.5
Other 0.5
3.Primary Outcome
Title Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
Hide Description Failure of initial empiric therapy was assessed by an independent committee of qualified healthcare professionals (surgeon, and microbiologist specialist) and defined as requirement of additional antibiotic or change in antibacterial therapy on any day following the initial laparotomy, laparoscopy, or percutaneous drainage; or additional laparotomy, laparoscopy, or percutaneous drainage at least 2 days following the initial surgical/radiological intervention; or participant death due to infection.
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants in which failure could be assessed
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: Percentage of participants
42.9
4.Primary Outcome
Title Duration of Hospitalization (by Failure of Initial Empiric Treatment)
Hide Description Yes equals (=) initial empiric antibiotic treatment failed (additional antibiotic therapy or a change in antibacterial therapy was required following laparotomy/laparoscopy or percutaneous draininge or participant died due to infection); No=initial empiric antibiotic treatment successful (infectious process resolved and no change in initial empiric antibiotic therapy was required during the course of hospitalization except for stepdown therapy, de-escalation or intravenous to oral switch).
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS; n=number of participants with nonmissing data
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 189
Mean (Standard Deviation)
Unit of Measure: Days
No (n=111) 8.9  (4.5)
Yes (n=78) 21.9  (16.4)
5.Secondary Outcome
Title Percentage of Participants With Specific Pathogen
Hide Description [Not Specified]
Time Frame Baseline up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: Percentage of participants
Escherichia coli 23.9
Pseudomonas aeruginosa 9.5
Klebsiella pneumoniae 9.0
Acinetobacter baumanii 8.5
Staphylococcus (S.) aureus (methicillin sensitive) 1.5
S. aureus (methicillin resistant) 1.0
Stenotrophomonas 0.5
Candida albicans 7.5
Candida species (spp) (non Albicans) 1.5
Fungi without species identification 0.5
S. epidermis 2.5
S. hominis 2.5
S. haemolyticus 1.0
S. lentus 0.5
S. intermedius 0.5
Enterococcus faecalis 10.9
Enterococcus faecium 7.0
Enterococcus durans 0.5
Enterococcus spp (vancomycin resistant) 2.0
Streptococcus viridans 1.5
Streptococcus salivarius 1.0
Streptococcus haemolyticus 1.0
Streptococcus mitis 1.0
Streptococcus pneumoniae 0.5
Streptococcus pyogenes 0.5
Streptococcus group C 0.5
Streptococcus Bovis 0.5
Streptococcus acidominimus 0.5
Bacteroides fragilis group 4.0
Enterobacter spp 2.0
Proteus spp 2.0
Proteus mirabilis 2.0
Bacteroides spp. (non fragilis) 1.0
Aeromonas hydrophila 1.0
Hafnia alvei 1.0
Enterobacter cloacae 1.0
Citrobacter braakii 1.0
Haemophilus spp 0.5
Morganella morganii 0.5
Prevotella bivia 0.5
Peptostreptococcus 0.5
Prevotella intermedia 0.5
Prevotella oralis 0.5
Actinomyces israelii 0.5
Enterobacter aerogenes 0.5
Ralstonia mannitolilytica 0.5
Comamonas acidovorans 0.5
Comamonas spp 0.5
Prevotella species 0.5
Citrobacter freundii 0.5
6.Secondary Outcome
Title Percentage of Participants by Diagnosis at Discharge
Hide Description [Not Specified]
Time Frame Month 6 or study exit
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description:
Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
Overall Number of Participants Analyzed 201
Measure Type: Number
Unit of Measure: Percentage of participants
Perforation of intestine 15.9
Acute appendicitis with (w/) peritoneal abscess 13.4
Postoperative peritonitis 13.4
Acute cholecystitis w/perforation 10.4
Acute appendicitis w/generalized peritionitis 10.0
Gastric ulcer w/ perforation 9.5
Duodenal ulcer w/perforation 7.0
Abscess of liver 4.5
Diverticulitis complicated 4.5
Fistula of intestine, excluding rectum and anus 3.0
cIAI: abdominal neplasm surgical extract/decrease 3.0
Gastrojejunal ulcer w/perforation 2.5
Gastrojejunal ulcer w/hemorrhage and perforatio 2.0
Abscess of intestine 2.0
Gastric ulcer w/hemorrhage and perforation 1.0
Peptic ulcer w/perforation 0.5
Peritonitis 0.5
Other 8.0
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event (AE) data were collected retrospectively by reviewing medical records using data available until December 2010. All death reports were sent to the Sponsor as case report forms upon identification in the database. In addition, the investigator retrospectively completed an AE/serious adverse event (SAE) form for any suspected AEs/SAEs.
 
Arm/Group Title All Enrolled Participants
Hide Arm/Group Description Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
All-Cause Mortality
All Enrolled Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Enrolled Participants
Affected / at Risk (%)
Total   20/201 (9.95%) 
Cardiac disorders   
Cardiac failure * 1  1/201 (0.50%) 
Cardiorespiratory arrest * 1  1/201 (0.50%) 
Myocardial infarction * 1  1/201 (0.50%) 
Gastrointestinal disorders   
Large intestine perforation * 1  2/201 (1.00%) 
Intra-abdominal haemorrhage * 1  1/201 (0.50%) 
Peritonitis * 1  1/201 (0.50%) 
Subdiaphragmatic abscess * 1  1/201 (0.50%) 
General disorders   
Unknown cause of death * 1  6/201 (2.99%) 
Multi-organ failure * 1  5/201 (2.49%) 
Systemic inflammatory response syndrome * 1  1/201 (0.50%) 
Hepatobiliary disorders   
Gallbladder perforation * 1  1/201 (0.50%) 
Infections and infestations   
Sepsis * 1  2/201 (1.00%) 
Septic shock * 1  1/201 (0.50%) 
Injury, poisoning and procedural complications   
Anastomotic complication * 1  1/201 (0.50%) 
Respiratory, thoracic and mediastinal disorders   
Cardiorespiratory arrest * 1  2/201 (1.00%) 
Respiratory failure * 1  1/201 (0.50%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Enrolled Participants
Affected / at Risk (%)
Total   0/201 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00929643     History of Changes
Other Study ID Numbers: 3074A1-102311
B1811060
First Submitted: June 26, 2009
First Posted: June 29, 2009
Results First Submitted: June 27, 2012
Results First Posted: August 6, 2012
Last Update Posted: August 10, 2012