Epidemiologic Study Evaluating Infections in Elderly Pati... | NCT00900952

Studies
Epidemiologic Study Evaluating Infections in Elderly Patients

NCT00900952

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Oct 9, 2009Estimated

Enrollment

240Actual

Phase

Not provided

Conditions

Infection

Interventions

Clinical record review

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

May 7, 2009

First Submission Date that Met QC Criteria

May 12, 2009

First Posted Date

May 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2009

Last Update Posted Date

Oct 9, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this observational study is to assess the prevalence and demographic and clinical characteristics of infections in elderly people admitted to Internal Medicine wards in Spain, as well as the etiology and resistance pattern for the main causal agents, and outcome.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Infected elderly patients	Other: Clinical record review

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical record review	Other		1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies.		5 months

Secondary Outcomes

Measure	Description	Time Frame
Study the etiology and resistance pattern for the main causal agents.		5 months
Describe the demographic features, co-morbidities, concomitant treatment and outcome of patients.		5 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients > 65 years of age that are hospitalized in an Internal Medicine ward and have an active infection (skin and soft tissue, intra-abdominal, or respiratory infections) from the community that needs antibiotic treatment
Patients must have at least one sample processed for microbiological diagnosis

Exclusion criteria:

COPD exacerbation
Urinary tract infections
Hospital acquired infections
Other infections not in inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Infected elderly patients treated at Internal Medicine wards in Spanish hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Mataró	Barcelona	08304	Spain

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided