Complicated Intra-Abdominal InfectionNCT00929643

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

An observational study of Complicated Intra-Abdominal Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Complicated Intra-Abdominal Infection
How many people: 203 participants
Where: 13 sitesGreece
Study dates: Nov 2008to Dec 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients hospitalized for complicated intra-abdominal infections

Who may be able to join

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;

Show all 19Show fewer

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.

Who cannot join

Patients not signing an informed consent form.
Patients participating in another interventional study.

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

Greece13 sites

Pfizer Investigational Site
Athens, Athens, 115 24
Pfizer Investigational Site
Athens, Athens, 115 26
Pfizer Investigational Site
Cholargós, Athens, 115 27
Pfizer Investigational Site
Haidari, Athens, 124 62
Pfizer Investigational Site
Heraklion, Vrete, 70013
Pfizer Investigational Site
Marousi, Athens, 151 26
Pfizer Investigational Site
N. Ionia, Athens, 142 33
Pfizer Investigational Site
Peireus, Athens, 184 54
Pfizer Investigational Site
Rio, Patras, 26500
Pfizer Investigational Site
Thessaloniki, Thessaloniki, 546 35
Pfizer Investigational Site
Thessaloniki, Thessaloniki, 546 42
Pfizer Investigational Site
Thessaloniki, Thessaloniki, 54636
Pfizer Investigational Site
Thessaloniki, Thessaloniki, 56429

Other trials in Greece

About this study

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

Read the 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.

Conditions: Complicated Intra-Abdominal Infection
Being tested: no intervention
Keywords: health care costs, Intra-Abdominal Infection
Medical subject headings: Intraabdominal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

no interventionOther
success of the initial empiric treatment

Study groups in NCT00929643
Study group	Role	What they receive
1		Not described Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of Hospitalization
Overall health care resource utilization was analyzed using mean duration of hospitalization.
Measured: Baseline up to 6 months
Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)
Measured: 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.
Measured: 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).
Measured: Baseline up to 6 months

Secondary outcomes (2)

Percentage of Participants With Specific Pathogen
Measured: Baseline up to 6 months
Percentage of Participants by Diagnosis at Discharge
Measured: Month 6 or study exit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2008Dec 2010

First posted29 Jun 2009 (estimated)
Study startNov 2008
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Complicated Intra-Abdominal InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929643
Sponsor's protocol ID: 3074A1-102311
Other IDs: B1811060
Status last verified: Aug 2012
First submitted: 26 Jun 2009
Last updated: 10 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
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Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
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RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection
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All Complicated Intra-Abdominal Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact Of Bacterial Resistance On Healthcare Costs For Hospitalized Patients With Complicated Intra-Abdominal Infections
ClinicalTrials.gov ID: NCT00929643
Acronym / sponsor ID: 3074A1-102311
Conditions: Complicated Intra-Abdominal Infection
Keywords: health care costs, Intra-Abdominal Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Nov 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 29 Jun 2009 (estimated)
Results: Posted 6 Aug 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Other: no intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients hospitalized for complicated intra-abdominal infections

Key inclusion criteria (19 listed)

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;

Key exclusion criteria (2 listed)

Patients not signing an informed consent form.
Patients participating in another interventional study.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
no interventionsuccess of the initial empiric treatment	Other	1

Primary outcome

Duration of Hospitalization
Time frame: 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)
Time frame: Baseline up to 6 months
Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy
Time frame: 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)
Time frame: 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).

2 secondary outcomes

Percentage of Participants With Specific Pathogen
Time frame: Baseline up to 6 months
Percentage of Participants by Diagnosis at Discharge
Time frame: Month 6 or study exit

Results and safety

Results posted to the registry on 6 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Participants	203	201

Primary outcome: Duration of Hospitalization

Time frame: Baseline up to 6 months. Mean (Standard Deviation). Unit: Days

Measure	All Enrolled Participants n = 193
Value	14.1 (12.7)

Population analysed: Full Analysis Set (FAS): All enrolled participants who fulfilled the protocol inclusion criteria. N=number of participants with nonmissing data.

Primary outcome: Percentage of Participants With Initial Empiric Antibiotic Therapy (by Therapeutic Class)

Time frame: Baseline up to 6 months. Number. Unit: Percentage of participants

Measure	All Enrolled Participants n = 201
Metronidazole	59.2
b-Lactamase Inhibitors (BLI)	38.3
Cephalosporines (2nd generation)	30.3
Quinolones	16.9
Aminoglycocides	12.4
Carbapenems	8.5
Glycopeptides	8.0
Glycycyclines	5.0

Population analysed: FAS

Primary outcome: Percentage of Participants With Failure of Initial Empiric Antibiotic Therapy

Time frame: Baseline up to 6 months. Number. Unit: Percentage of participants

Measure	All Enrolled Participants n = 196
Value	42.9

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

Primary outcome: Duration of Hospitalization (by Failure of Initial Empiric Treatment)

Time frame: Baseline up to 6 months. Mean (Standard Deviation). Unit: Days

Measure	All Enrolled Participants n = 189
No (n=111)	8.9 (4.5)
Yes (n=78)	21.9 (16.4)

Population analysed: FAS; n=number of participants with nonmissing data

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Participants	20 of 201 (10%)	0 of 201 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Complicated Intra-Abdominal Infection

RecruitingPhase 2
Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections
Gram-negative Bacterial Infections
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Complicated Intra-Abdominal Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 13 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of Hospitalization (time frame: Baseline up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00929643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2012.