Trial Outcomes & Findings for Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections (NCT NCT00929643)
NCT ID: NCT00929643
Last Updated: 2012-08-10
Results Overview
Overall health care resource utilization was analyzed using mean duration of hospitalization.
Recruitment status
COMPLETED
Target enrollment
203 participants
Primary outcome timeframe
Baseline up to 6 months
Results posted on
2012-08-10
Participant Flow
Observational, epidemiological, noninterventional study.
Participant milestones
| Measure |
All Enrolled Participants
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.
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|---|---|
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Overall Study
STARTED
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203
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Overall Study
COMPLETED
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201
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
All Enrolled Participants
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.
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|---|---|
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Overall Study
Protocol Violation
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2
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Baseline Characteristics
Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=201 Participants
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.
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|---|---|
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Age Continuous
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57.4 Years
STANDARD_DEVIATION 19.7 • n=5 Participants
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Sex: Female, Male
Female
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65 Participants
n=5 Participants
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Sex: Female, Male
Male
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136 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.
Overall health care resource utilization was analyzed using mean duration of hospitalization.
Outcome measures
| Measure |
All Enrolled Participants
n=193 Participants
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.
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|---|---|
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Duration of Hospitalization
|
14.1 Days
Standard Deviation 12.7
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PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: FAS
Outcome measures
| Measure |
All Enrolled Participants
n=201 Participants
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.
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|---|---|
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Metronidazole
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59.2 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
b-Lactamase Inhibitors (BLI)
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38.3 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Cephalosporines (2nd generation)
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30.3 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Quinolones
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16.9 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Aminoglycocides
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12.4 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Carbapenems
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8.5 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Glycopeptides
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8.0 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Glycycyclines
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5.0 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Antifungals
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4.0 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Cephalosporines (3rd generation)
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4.0 Percentage of participants
|
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Lipopeptides/oxazolidinones
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2.0 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Clindamycin
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1.5 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Beta lactams
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0.5 Percentage of participants
|
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Cephalosporines (4th generation)
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0.5 Percentage of participants
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Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Other
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0.5 Percentage of participants
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PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: FAS; n=number of participants in which failure could be assessed
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.
Outcome measures
| Measure |
All Enrolled Participants
n=196 Participants
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.
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|---|---|
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Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
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42.9 Percentage of participants
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PRIMARY outcome
Timeframe: Baseline up to 6 monthsPopulation: FAS; n=number of participants with nonmissing data
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).
Outcome measures
| Measure |
All Enrolled Participants
n=189 Participants
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.
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|---|---|
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Duration of Hospitalization (by Failure of Initial Empiric Treatment)
No (n=111)
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8.9 Days
Standard Deviation 4.5
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Duration of Hospitalization (by Failure of Initial Empiric Treatment)
Yes (n=78)
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21.9 Days
Standard Deviation 16.4
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SECONDARY outcome
Timeframe: Baseline up to 6 monthsPopulation: FAS
Outcome measures
| Measure |
All Enrolled Participants
n=201 Participants
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.
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|---|---|
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Percentage of Participants With Specific Pathogen
Escherichia coli
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23.9 Percentage of participants
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Percentage of Participants With Specific Pathogen
Pseudomonas aeruginosa
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9.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Klebsiella pneumoniae
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9.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Acinetobacter baumanii
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8.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Staphylococcus (S.) aureus (methicillin sensitive)
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1.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. aureus (methicillin resistant)
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Stenotrophomonas
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Candida albicans
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7.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Candida species (spp) (non Albicans)
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1.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Fungi without species identification
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. epidermis
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2.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. hominis
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2.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. haemolyticus
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. lentus
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
S. intermedius
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterococcus faecalis
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10.9 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterococcus faecium
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7.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterococcus durans
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterococcus spp (vancomycin resistant)
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2.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus viridans
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1.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus salivarius
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus haemolyticus
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus mitis
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus pneumoniae
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus pyogenes
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus group C
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus Bovis
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Streptococcus acidominimus
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Bacteroides fragilis group
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4.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterobacter spp
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2.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Proteus spp
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2.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Proteus mirabilis
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2.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Bacteroides spp. (non fragilis)
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Aeromonas hydrophila
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Hafnia alvei
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Enterobacter cloacae
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Citrobacter braakii
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1.0 Percentage of participants
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Percentage of Participants With Specific Pathogen
Haemophilus spp
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Morganella morganii
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Prevotella bivia
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Peptostreptococcus
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Prevotella intermedia
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Prevotella oralis
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0.5 Percentage of participants
|
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Percentage of Participants With Specific Pathogen
Actinomyces israelii
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0.5 Percentage of participants
|
|
Percentage of Participants With Specific Pathogen
Enterobacter aerogenes
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0.5 Percentage of participants
|
|
Percentage of Participants With Specific Pathogen
Ralstonia mannitolilytica
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0.5 Percentage of participants
|
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Percentage of Participants With Specific Pathogen
Comamonas acidovorans
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Comamonas spp
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Prevotella species
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0.5 Percentage of participants
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Percentage of Participants With Specific Pathogen
Citrobacter freundii
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0.5 Percentage of participants
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SECONDARY outcome
Timeframe: Month 6 or study exitPopulation: FAS
Outcome measures
| Measure |
All Enrolled Participants
n=201 Participants
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.
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|---|---|
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Percentage of Participants by Diagnosis at Discharge
Other
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8.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Perforation of intestine
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15.9 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Acute appendicitis with (w/) peritoneal abscess
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13.4 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Postoperative peritonitis
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13.4 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Acute cholecystitis w/perforation
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10.4 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Acute appendicitis w/generalized peritionitis
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10.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Gastric ulcer w/ perforation
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9.5 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Duodenal ulcer w/perforation
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7.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Abscess of liver
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4.5 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Diverticulitis complicated
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4.5 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Fistula of intestine, excluding rectum and anus
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3.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
cIAI: abdominal neplasm surgical extract/decrease
|
3.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Gastrojejunal ulcer w/perforation
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2.5 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Gastrojejunal ulcer w/hemorrhage and perforatio
|
2.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Abscess of intestine
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2.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Gastric ulcer w/hemorrhage and perforation
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1.0 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Peptic ulcer w/perforation
|
0.5 Percentage of participants
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Percentage of Participants by Diagnosis at Discharge
Peritonitis
|
0.5 Percentage of participants
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Adverse Events
All Enrolled Participants
Serious events: 20 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Enrolled Participants
n=201 participants at risk
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.
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|---|---|
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General disorders
Unknown cause of death
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3.0%
6/201
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.
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General disorders
Multi-organ failure
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2.5%
5/201
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.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.50%
1/201
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.
|
|
Gastrointestinal disorders
Large intestine perforation
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1.00%
2/201
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.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.50%
1/201
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.
|
|
Gastrointestinal disorders
Peritonitis
|
0.50%
1/201
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.
|
|
Gastrointestinal disorders
Subdiaphragmatic abscess
|
0.50%
1/201
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.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/201
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.
|
|
Cardiac disorders
Cardiorespiratory arrest
|
0.50%
1/201
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.
|
|
Cardiac disorders
Myocardial infarction
|
0.50%
1/201
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.
|
|
Infections and infestations
Sepsis
|
1.00%
2/201
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.
|
|
Infections and infestations
Septic shock
|
0.50%
1/201
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.
|
|
Respiratory, thoracic and mediastinal disorders
Cardiorespiratory arrest
|
1.00%
2/201
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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.50%
1/201
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.
|
|
Hepatobiliary disorders
Gallbladder perforation
|
0.50%
1/201
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.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.50%
1/201
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER