PneumoniaNCT01741909
Reducing Cost of Azythromycin by Transferring From IV to Oral Therapy
A study testing education in people with Pneumonia, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The investigators believe that intravenous therapy is prolonged more that necessary and that oral therapy can be used much earlier in the course of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- education
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients hospitalized with community acquired pneumonia treated by azythromycin
Who cannot join
- Age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can the Cost of Azythromycin in be Reduced in Hospitalized Patients With Community Acquired Pneumonia by Quick Transfer From Intravenous to Oral Therapy?
Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The investigators believe that intravenous therapy is prolonged more that necessary and that oral therapy can be used much earlier in the course of the disease. The investigators plan to check if that statement is true and intervene in order to shorten the intravenous therapy.
Read the detailed description
The study will be performed in two stages. First a retrospective review of medical files of 50 patients hospitalized in the Haemek Medical Center with severe community acquired pneumonia, treated with azythromycin. The files will be reviewed for the criteria clinical improvement, and for azythromycin therapy, oral or intravenous.
The results of this review will help us define the appropriate behavioral intervention in order to cause doctors to transfer from IV to PO therapy at the earliest appropriate time. An intervention such as posters, pharmacy overseeing etc will be introduced. 3 months after the intervention, an additional 50 files of pneumonia patients treated with azythromycin will be reviewed in order to check the efficacy of the intervention.
The Review board and the NIH will be updated about the intervention, as soon as the investigators have decided what intervention is appropriate
- Conditions
- Pneumonia
- Being tested
- education
- Keywords
- azythromycin, community acquired pneumonia, intravenous, oral
- Medical subject headings
- Pneumonia, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationBehavioural
after a baseline period, shorter intravenous treatment will be promoted by mail, posters, lectures, and pharmacy monitoring of treatment
| Study group | Role | What they receive |
|---|---|---|
| Before, After | Experimental | The intervention is educational Receives: Behavioral: education |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of intravenous azythromycin treatment
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 posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Due to recruiting issues
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Goldstein, HaEmek Medical Center, Israel
- Investigators
- Lee H Goldstein, MD, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741909
- Sponsor's protocol ID
- EMC-85-12-CTIL
- Status last verified
- Aug 2016
- First submitted
- 2 Dec 2012
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Cost of Azythromycin in be Reduced in Hospitalized Patients With Community Acquired Pneumonia by Quick Transfer From Intravenous to Oral Therapy?
- ClinicalTrials.gov ID
- NCT01741909
- Acronym / sponsor ID
- EMC-85-12-CTIL
- Conditions
- Pneumonia
- Keywords
- azythromycin, community acquired pneumonia, intravenous, oral
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to recruiting issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Dec 2012 (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.
Intravenous Azythromycin therapy is considerably more expensive than oral therapy. The investigators believe that intravenous therapy is prolonged more that necessary and that oral therapy can be used much earlier in the course of the disease. The investigators plan to check if that statement is true and intervene in order to shorten the intravenous therapy.
Detailed description
The study will be performed in two stages. First a retrospective review of medical files of 50 patients hospitalized in the Haemek Medical Center with severe community acquired pneumonia, treated with azythromycin. The files will be reviewed for the criteria clinical improvement, and for azythromycin therapy, oral or intravenous.
The results of this review will help us define the appropriate behavioral intervention in order to cause doctors to transfer from IV to PO therapy at the earliest appropriate time. An intervention such as posters, pharmacy overseeing etc will be introduced. 3 months after the intervention, an additional 50 files of pneumonia patients treated with azythromycin will be reviewed in order to check the efficacy of the intervention.
The Review board and the NIH will be updated about the intervention, as soon as the investigators have decided what intervention is appropriate
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Before, After | Experimental | Behavioral: educationThe intervention is educational |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients hospitalized with community acquired pneumonia treated by azythromycin
Key exclusion criteria (1 listed)
- Age under 18
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 |
|---|---|---|
| educationafter a baseline period, shorter intravenous treatment will be promoted by mail, posters, lectures, and pharmacy monitoring of treatment | Behavioural | Before, After |
Primary outcome
length of intravenous azythromycin treatment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
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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.
Lee H Goldstein, MD principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Pneumonia, run by HaEmek Medical Center, Israel at 1 site in Israel.
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: withdrawn, as of the sponsor's last update on 31 Aug 2016. 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
length of intravenous azythromycin treatment (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 31 Aug 2016.