N/A
N=203
Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
Complicated Intra-Abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT00929643 ↗Enrolled (actual)
203
Serious AEs
10.0%
Results posted
Aug 2012
Primary outcome: Primary: Duration of Hospitalization — 14.1 Days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- no intervention (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Hospitalization |
14.1 | — |
| PRIMARY Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) |
59.2; 38.3; 30.3; 16.9; 12.4; 8.5 | — |
| PRIMARY Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy |
42.9 | — |
| PRIMARY Duration of Hospitalization (by Failure of Initial Empiric Treatment) |
8.9; 21.9 | — |
| SECONDARY Percentage of Participants With Specific Pathogen |
23.9; 9.5; 9.0; 8.5; 1.5; 1.0 | — |
| SECONDARY Percentage of Participants by Diagnosis at Discharge |
15.9; 13.4; 13.4; 10.4; 10.0; 9.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00929643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.