PneumoniaNCT03046082
Anaerobic Antibiotic Usage for Pneumonia in the Medical Intensive Care Unit
An observational study of Pneumonia, run by Henry Ford Health System.
Trial summary
Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU with pneumonia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pneumonia
- What is being tested?
- Antibiotics
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the intensive care unit with a diagnosis of pneumonia.
Who may be able to join
- ICU patients with diagnosis of pneumonia
Who cannot join
- patients with abdominal infections such as c diff.
About this study
Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU with pneumonia.
Read the detailed description
Pneumonia is a common admitting diagnosis in the intensive care unit (ICU). When aspiration is suspected, antibiotics to cover anaerobes are frequently used , but in the absence of clear risk factors, current guidelines have questioned their role. It is unknown how frequently these guidelines are followed.
- Conditions
- Pneumonia
- Being tested
- Antibiotics
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Observation of antibiotic types given to patients with pneumonia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Usage of anaerobic antibiotics
Percent of patients receiving inappropriate anaerobic antibiotics
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Jennings, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046082
- Sponsor's protocol ID
- 10229
- Status last verified
- Nov 2023
- First submitted
- 6 Feb 2017
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anaerobic Antibiotic Usage for Pneumonia in the Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03046082
- Acronym / sponsor ID
- 10229
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Feb 2017 (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.
Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU with pneumonia.
Detailed description
Pneumonia is a common admitting diagnosis in the intensive care unit (ICU). When aspiration is suspected, antibiotics to cover anaerobes are frequently used , but in the absence of clear risk factors, current guidelines have questioned their role. It is unknown how frequently these guidelines are followed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the intensive care unit with a diagnosis of pneumonia.
Key inclusion criteria (1 listed)
- ICU patients with diagnosis of pneumonia
Key exclusion criteria (1 listed)
- patients with abdominal infections such as c diff.
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 |
|---|---|---|
| AntibioticsObservation of antibiotic types given to patients with pneumonia. | Drug | – |
Primary outcome
Usage of anaerobic antibiotics
Time frame: 6 months
Percent of patients receiving inappropriate anaerobic antibiotics
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 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Henry Ford Health System.
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 1 inclusion and 1 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Usage of anaerobic antibiotics (time frame: 6 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 30 Nov 2023.