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

This study has been completed.

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00929643

First received: June 26, 2009

Last updated: August 6, 2012

Last verified: August 2012

History of Changes

Results First Received: June 27, 2012

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Complicated Intra-Abdominal Infection
Intervention:	Other: no intervention

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Observational, epidemiological, noninterventional study.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	All Enrolled Participants
STARTED	203
COMPLETED	201
NOT COMPLETED	2
Protocol Violation	2

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	All Enrolled Participants
Number of Participants [units: participants]	201
Age [units: Years] Mean ± Standard Deviation	57.4 ± 19.7
Gender [units: Participants]
Female	65
Male	136

Outcome Measures

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1. Primary:

Duration of Hospitalization [ Time Frame: Baseline up to 6 months ]

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2. Primary:

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

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3. Primary:

Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy [ Time Frame: Baseline up to 6 months ]

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4. Primary:

Duration of Hospitalization (by Failure of Initial Empiric Treatment) [ Time Frame: Baseline up to 6 months ]

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5. Secondary:

Percentage of Participants With Specific Pathogen [ Time Frame: Baseline up to 6 months ]

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6. Secondary:

Percentage of Participants by Diagnosis at Discharge [ Time Frame: Month 6 or study exit ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00929643 History of Changes
Other Study ID Numbers:	3074A1-102311, B1811060
Study First Received:	June 26, 2009
Results First Received:	June 27, 2012
Last Updated:	August 6, 2012
Health Authority:	Greece: National Organization of Medicines

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