InfectionNCT00900952
Epidemiologic Study Evaluating Infections in Elderly Patients
An observational study of Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Infection
- What is being tested?
- Clinical record review
- How many people
- 240 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2009to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Infected elderly patients treated at Internal Medicine wards in Spanish hospitals
Who may be able to join
- 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
Who cannot join
- COPD exacerbation
- Urinary tract infections
- Hospital acquired infections
- Other infections not in inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiologic Study of Infections in Elderly Patients
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.
- Conditions
- Infection
- Being tested
- Clinical record review
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical record reviewOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | Infected elderly patients Receives: Other: Clinical record review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies.
Measured: 5 months
Secondary outcomes (2)
Study the etiology and resistance pattern for the main causal agents.
Measured: 5 months
Describe the demographic features, co-morbidities, concomitant treatment and outcome of patients.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMar 2009
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900952
- Sponsor's protocol ID
- 3074X1-4489
- Status last verified
- Oct 2009
- First submitted
- 7 May 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic Study of Infections in Elderly Patients
- ClinicalTrials.gov ID
- NCT00900952
- Acronym / sponsor ID
- 3074X1-4489
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Clinical record reviewInfected elderly patients |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Infected elderly patients treated at Internal Medicine wards in Spanish hospitals
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- COPD exacerbation
- Urinary tract infections
- Hospital acquired infections
- Other infections not in inclusion criteria
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 |
|---|---|---|
| Clinical record review | Other | 1 |
Primary outcome
Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies.
Time frame: 5 months
2 secondary outcomes
Study the etiology and resistance pattern for the main causal agents.
Time frame: 5 months
Describe the demographic features, co-morbidities, concomitant treatment and outcome of patients.
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2009.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in Spain.
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 2 inclusion and 4 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 9 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of each kind of infection will be measured from a descriptive point of view, using relative and absolute frequencies. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2009.