Complicated Intra-Abdominal Infection
Conditions
Keywords
health care costs, Intra-Abdominal Infection
Brief summary
The objective of this study is to estimate the costs of empiric antibiotic therapy and hospitalization costs for patients with a complicated intra-abdominal infection, and to assess the impact of treatment failure of initial antibiotic empiric therapy on pharmacological and total healthcare costs for these patients in Greece.
Detailed description
Every patient diagnosed with complicated intra-abdominal infections will enter the study, until the pre-specified number of patients is reached. Patients diagnosed with any of conditions mentioned below (inclusion criteria) will enter the study, until the pre-specified number of patients is reached.
Interventions
OTHERno intervention
success of the initial empiric treatment
Sponsors
Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A recorded primary diagnosis of a complicated intra-abdominal. infection (cIAI) and a procedure involving a laparotomy, laparoscopy, or percutaneous drainage of an intra-abdominal abscess The study will be a prospective, multi-centre, epidemiological study of patients (aged \> 18 years) diagnosed with a complicated intra-abdominal infection AND who received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess. cIAI's will include the following conditions/ diagnoses: * Gastric ulcer with perforation; * Gastric ulcer with hemorrhage and perforation; * Duodenal ulcer with perforation; * Duodenal ulcer with hemorrhage and perforation; * Peptic ulcer with perforation; * Peptic ulcer with hemorrhage and perforation; * Gastrojejunal ulcer with perforation; * Gastrojejunal ulcer with hemorrhage and perforation; * Acute appendicitis with generalized peritonitis; * Acute appendicitis with peritoneal abscess; * Peritonitis; * Abscess of intestine; * Fistula of intestine, excluding rectum and anus; * Ulceration of intestine; * Perforation of intestine; * Abscess of liver; or * Acute cholecystitis with perforation. The initial antibiotic regimen will be defined as all IV antibiotics newly received either on the day immediately prior to laparotomy or laparoscopy or percutaneous drainage of an intra-abdominal abscess, or on the day of these procedures, given that the use of these procedures prior to initiation of IV antibiotic regimens in complicated IAIs , which is increasingly common, is likely reflective of prophylaxis.
Exclusion criteria
* Patients not signing an informed consent form. * Patients participating in another interventional study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Hospitalization | Baseline up to 6 months | Overall health care resource utilization was analyzed using mean duration of hospitalization. |
| Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Baseline up to 6 months | — |
| Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy | Baseline up to 6 months | 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. |
| Duration of Hospitalization (by Failure of Initial Empiric Treatment) | Baseline up to 6 months | 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). |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Specific Pathogen | Baseline up to 6 months |
| Percentage of Participants by Diagnosis at Discharge | Month 6 or study exit |
Countries
Greece
Participant flow
Pre-assignment details
Observational, epidemiological, noninterventional study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 201 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age Continuous | 57.4 Years STANDARD_DEVIATION 19.7 |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 201 |
| serious Total, serious adverse events | 20 / 201 |
Outcome results
Primary
Duration of Hospitalization
Overall health care resource utilization was analyzed using mean duration of hospitalization.
Time frame: Baseline up to 6 months
Population: Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Enrolled Participants | Duration of Hospitalization | 14.1 Days | Standard Deviation 12.7 |
Primary
Duration of Hospitalization (by Failure of Initial Empiric Treatment)
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
Population: FAS; n=number of participants with nonmissing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Participants | Duration of Hospitalization (by Failure of Initial Empiric Treatment) | No (n=111) | 8.9 Days | Standard Deviation 4.5 |
| All Enrolled Participants | Duration of Hospitalization (by Failure of Initial Empiric Treatment) | Yes (n=78) | 21.9 Days | Standard Deviation 16.4 |
Primary
Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
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
Population: FAS; n=number of participants in which failure could be assessed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Enrolled Participants | Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy | 42.9 Percentage of participants |
Primary
Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Time frame: Baseline up to 6 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Metronidazole | 59.2 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | b-Lactamase Inhibitors (BLI) | 38.3 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Cephalosporines (2nd generation) | 30.3 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Quinolones | 16.9 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Aminoglycocides | 12.4 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Carbapenems | 8.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Glycopeptides | 8.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Glycycyclines | 5.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Antifungals | 4.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Cephalosporines (3rd generation) | 4.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Lipopeptides/oxazolidinones | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Clindamycin | 1.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Beta lactams | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Cephalosporines (4th generation) | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) | Other | 0.5 Percentage of participants |
Secondary
Percentage of Participants by Diagnosis at Discharge
Time frame: Month 6 or study exit
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Perforation of intestine | 15.9 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Acute appendicitis with (w/) peritoneal abscess | 13.4 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Postoperative peritonitis | 13.4 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Acute cholecystitis w/perforation | 10.4 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Acute appendicitis w/generalized peritionitis | 10.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Gastric ulcer w/ perforation | 9.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Duodenal ulcer w/perforation | 7.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Abscess of liver | 4.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Diverticulitis complicated | 4.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Fistula of intestine, excluding rectum and anus | 3.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | cIAI: abdominal neplasm surgical extract/decrease | 3.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Gastrojejunal ulcer w/perforation | 2.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Gastrojejunal ulcer w/hemorrhage and perforatio | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Abscess of intestine | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Gastric ulcer w/hemorrhage and perforation | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Peptic ulcer w/perforation | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Peritonitis | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants by Diagnosis at Discharge | Other | 8.0 Percentage of participants |
Secondary
Percentage of Participants With Specific Pathogen
Time frame: Baseline up to 6 months
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Prevotella bivia | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Peptostreptococcus | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Escherichia coli | 23.9 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Pseudomonas aeruginosa | 9.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Klebsiella pneumoniae | 9.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Acinetobacter baumanii | 8.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Staphylococcus (S.) aureus (methicillin sensitive) | 1.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. aureus (methicillin resistant) | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Stenotrophomonas | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Fungi without species identification | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. epidermis | 2.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. hominis | 2.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. haemolyticus | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. lentus | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | S. intermedius | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterococcus faecalis | 10.9 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterococcus faecium | 7.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterococcus durans | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterococcus spp (vancomycin resistant) | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus viridans | 1.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus salivarius | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus haemolyticus | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus mitis | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus pneumoniae | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus pyogenes | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus group C | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus Bovis | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Streptococcus acidominimus | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Bacteroides fragilis group | 4.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterobacter spp | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Proteus spp | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Proteus mirabilis | 2.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Bacteroides spp. (non fragilis) | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Aeromonas hydrophila | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Hafnia alvei | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterobacter cloacae | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Citrobacter braakii | 1.0 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Haemophilus spp | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Morganella morganii | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Candida albicans | 7.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Candida species (spp) (non Albicans) | 1.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Prevotella intermedia | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Prevotella oralis | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Actinomyces israelii | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Enterobacter aerogenes | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Ralstonia mannitolilytica | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Comamonas acidovorans | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Comamonas spp | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Prevotella species | 0.5 Percentage of participants |
| All Enrolled Participants | Percentage of Participants With Specific Pathogen | Citrobacter freundii | 0.5 Percentage of participants |