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

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00929643
• Collaborator: Pfizer (Industry)
• Enrollment: 203
• Locations: 13
• Duration (Months): 25
• Patients Per Site: 15.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Intra-Abdominal Infection	Other: no intervention

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 203 participants
• Time Perspective: Prospective
• Official Title: The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
1	Other: no intervention; success of the initial empiric treatment

Outcome Measures

Primary Outcome Measures

1. Duration of Hospitalization [Baseline up to 6 months]

   Overall health care resource utilization was analyzed using mean duration of hospitalization.

2. Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class) [Baseline up to 6 months]

3. 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.

4. 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 Outcome Measures

1. Percentage of Participants With Specific Pathogen [Baseline up to 6 months]

2. Percentage of Participants by Diagnosis at Discharge [Month 6 or study exit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Haidari	Athens	Greece	124 62
2	Pfizer Investigational Site	Holargos	Athens	Greece	115 27
3	Pfizer Investigational Site	Marousi	Athens	Greece	151 26
4	Pfizer Investigational Site	N. Ionia	Athens	Greece	142 33
5	Pfizer Investigational Site	Peireus	Athens	Greece	184 54
6	Pfizer Investigational Site	Rio	Patras	Greece	26500
7	Pfizer Investigational Site	Herakleion	Vrete	Greece	70013
8	Pfizer Investigational Site	Athens		Greece	115 24
9	Pfizer Investigational Site	Athens		Greece	115 26
10	Pfizer Investigational Site	Thessaloniki		Greece	546 35
11	Pfizer Investigational Site	Thessaloniki		Greece	546 42
12	Pfizer Investigational Site	Thessaloniki		Greece	54636
13	Pfizer Investigational Site	Thessaloniki		Greece	56429

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer
• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT00929643
• Other Study ID Numbers: 3074A1-102311; B1811060
• First Posted: Jun 29, 2009
• Last Update Posted: Aug 10, 2012
• Last Verified: Aug 1, 2012

• Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer: health care costs; Intra-Abdominal Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Intraabdominal Infections

Study Results

Participant Flow

Pre-assignment Detail	Observational, epidemiological, noninterventional study.

Arm/Group Title	All Enrolled Participants
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

Baseline Characteristics

Arm/Group Title	All Enrolled Participants
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 Participants	201
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	57.4 (19.7)
Sex: Female, Male (Count of Participants)
Female	65 32.3%
Male	136 67.7%

Outcome Measures

1. Primary Outcome

Title	Duration of Hospitalization
Description	Overall health care resource utilization was analyzed using mean duration of hospitalization.
Time Frame	Baseline up to 6 months

Outcome Measure Data

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
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.
Measure Participants	193
Mean (Standard Deviation) [Days]	14.1 (12.7)

2. Primary Outcome

Title	Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Time Frame	Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	All Enrolled Participants
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.
Measure Participants	201
Metronidazole	59.2 29.5%
b-Lactamase Inhibitors (BLI)	38.3 19.1%
Cephalosporines (2nd generation)	30.3 15.1%
Quinolones	16.9 8.4%
Aminoglycocides	12.4 6.2%
Carbapenems	8.5 4.2%
Glycopeptides	8.0 4%
Glycycyclines	5.0 2.5%
Antifungals	4.0 2%
Cephalosporines (3rd generation)	4.0 2%
Lipopeptides/oxazolidinones	2.0 1%
Clindamycin	1.5 0.7%
Beta lactams	0.5 0.2%
Cephalosporines (4th generation)	0.5 0.2%
Other	0.5 0.2%

3. Primary Outcome

Title	Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
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

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants in which failure could be assessed

Arm/Group Title	All Enrolled Participants
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.
Measure Participants	196
Number [Percentage of participants]	42.9 21.3%

4. Primary Outcome

Title	Duration of Hospitalization (by Failure of Initial Empiric Treatment)
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

Outcome Measure Data

Analysis Population Description

FAS; n=number of participants with nonmissing data

Arm/Group Title	All Enrolled Participants
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.
Measure Participants	189
No (n=111)	8.9 (4.5)
Yes (n=78)	21.9 (16.4)

5. Secondary Outcome

Title	Percentage of Participants With Specific Pathogen
Time Frame	Baseline up to 6 months

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	All Enrolled Participants
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.
Measure Participants	201
Escherichia coli	23.9 11.9%
Pseudomonas aeruginosa	9.5 4.7%
Klebsiella pneumoniae	9.0 4.5%
Acinetobacter baumanii	8.5 4.2%
Staphylococcus (S.) aureus (methicillin sensitive)	1.5 0.7%
S. aureus (methicillin resistant)	1.0 0.5%
Stenotrophomonas	0.5 0.2%
Candida albicans	7.5 3.7%
Candida species (spp) (non Albicans)	1.5 0.7%
Fungi without species identification	0.5 0.2%
S. epidermis	2.5 1.2%
S. hominis	2.5 1.2%
S. haemolyticus	1.0 0.5%
S. lentus	0.5 0.2%
S. intermedius	0.5 0.2%
Enterococcus faecalis	10.9 5.4%
Enterococcus faecium	7.0 3.5%
Enterococcus durans	0.5 0.2%
Enterococcus spp (vancomycin resistant)	2.0 1%
Streptococcus viridans	1.5 0.7%
Streptococcus salivarius	1.0 0.5%
Streptococcus haemolyticus	1.0 0.5%
Streptococcus mitis	1.0 0.5%
Streptococcus pneumoniae	0.5 0.2%
Streptococcus pyogenes	0.5 0.2%
Streptococcus group C	0.5 0.2%
Streptococcus Bovis	0.5 0.2%
Streptococcus acidominimus	0.5 0.2%
Bacteroides fragilis group	4.0 2%
Enterobacter spp	2.0 1%
Proteus spp	2.0 1%
Proteus mirabilis	2.0 1%
Bacteroides spp. (non fragilis)	1.0 0.5%
Aeromonas hydrophila	1.0 0.5%
Hafnia alvei	1.0 0.5%
Enterobacter cloacae	1.0 0.5%
Citrobacter braakii	1.0 0.5%
Haemophilus spp	0.5 0.2%
Morganella morganii	0.5 0.2%
Prevotella bivia	0.5 0.2%
Peptostreptococcus	0.5 0.2%
Prevotella intermedia	0.5 0.2%
Prevotella oralis	0.5 0.2%
Actinomyces israelii	0.5 0.2%
Enterobacter aerogenes	0.5 0.2%
Ralstonia mannitolilytica	0.5 0.2%
Comamonas acidovorans	0.5 0.2%
Comamonas spp	0.5 0.2%
Prevotella species	0.5 0.2%
Citrobacter freundii	0.5 0.2%

6. Secondary Outcome

Title	Percentage of Participants by Diagnosis at Discharge
Time Frame	Month 6 or study exit

Outcome Measure Data

Analysis Population Description

FAS

Arm/Group Title	All Enrolled Participants
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.
Measure Participants	201
Perforation of intestine	15.9 7.9%
Acute appendicitis with (w/) peritoneal abscess	13.4 6.7%
Postoperative peritonitis	13.4 6.7%
Acute cholecystitis w/perforation	10.4 5.2%
Acute appendicitis w/generalized peritionitis	10.0 5%
Gastric ulcer w/ perforation	9.5 4.7%
Duodenal ulcer w/perforation	7.0 3.5%
Abscess of liver	4.5 2.2%
Diverticulitis complicated	4.5 2.2%
Fistula of intestine, excluding rectum and anus	3.0 1.5%
cIAI: abdominal neplasm surgical extract/decrease	3.0 1.5%
Gastrojejunal ulcer w/perforation	2.5 1.2%
Gastrojejunal ulcer w/hemorrhage and perforatio	2.0 1%
Abscess of intestine	2.0 1%
Gastric ulcer w/hemorrhage and perforation	1.0 0.5%
Peptic ulcer w/perforation	0.5 0.2%
Peritonitis	0.5 0.2%
Other	8.0 4%

Adverse Events

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
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	20/201 (10%)
Cardiac disorders
Cardiac failure	1/201 (0.5%)
Cardiorespiratory arrest	1/201 (0.5%)
Myocardial infarction	1/201 (0.5%)
Gastrointestinal disorders
Large intestine perforation	2/201 (1%)
Intra-abdominal haemorrhage	1/201 (0.5%)
Peritonitis	1/201 (0.5%)
Subdiaphragmatic abscess	1/201 (0.5%)
General disorders
Unknown cause of death	6/201 (3%)
Multi-organ failure	5/201 (2.5%)
Systemic inflammatory response syndrome	1/201 (0.5%)
Hepatobiliary disorders
Gallbladder perforation	1/201 (0.5%)
Infections and infestations
Sepsis	2/201 (1%)
Septic shock	1/201 (0.5%)
Injury, poisoning and procedural complications
Anastomotic complication	1/201 (0.5%)
Respiratory, thoracic and mediastinal disorders
Cardiorespiratory arrest	2/201 (1%)
Respiratory failure	1/201 (0.5%)
Other (Not Including Serious) Adverse Events
	All Enrolled Participants
	Affected / at Risk (%)	# Events
Total	0/201 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.