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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Complicated Intra-Abdominal Infection

Intervention / Treatment
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* Other: no intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Other: no intervention<br>* success of the initial empiric treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Hospitalization | Overall health care resource utilization was analyzed using mean duration of hospitalization. | Baseline up to 6 months | 
| 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 | 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. | Baseline up to 6 months | 
| 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). | Baseline up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health care costs, Intra-Abdominal Infection