Infectious DiseasesNCT00550706
Drug Utilization Prevalence in a Pediatric Care Medical Center
An observational study of Infectious Diseases and Metabolic Diseases, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Infectious Diseases, Metabolic Diseases, Cancer
- How many people
- 567 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Apr 2008
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Admitted children for medical treatment in two different pediatric departments
Who may be able to join
- All admitted children receiving at least one prescribed or OTC medication.
Who cannot join
- All admitted children who do not get a prescribed or OTC medication.
Trial locations and contacts
1 site in 1 country.
About this study
One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered.
- Conditions
- Infectious Diseases, Metabolic Diseases, Cancer
- Keywords
- Prescription point prevalence, Drug utilization, Define Daily Dose
- Medical subject headings
- Communicable Diseases, Metabolic Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1Pediatric Dept A | Children's files from this department will be analysed once weekly and medication prescription data will be registered | |
| 2 Pediatric Dept B | Children's files from this department will be analysed once weekly and medication prescription data will be registered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive use of medications
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 567 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norberto Krivoy, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550706
- Sponsor's protocol ID
- PDU2724_CTIL
- Status last verified
- Jun 2013
- First submitted
- 29 Oct 2007
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Prevalence in a Pediatric Care Medical Center
- ClinicalTrials.gov ID
- NCT00550706
- Acronym / sponsor ID
- PDU2724_CTIL
- Conditions
- Infectious Diseases, Metabolic Diseases, Cancer
- Keywords
- Prescription point prevalence, Drug utilization, Define Daily Dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 567 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 30 Oct 2007 (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.
One year prospective analysis of drug utilization and prescription point prevalence of medications in a pediatric tertiary care university medical center. Off-label use of medications in the study population will be also registered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1Pediatric Dept A | – | –Children's files from this department will be analysed once weekly and medication prescription data will be registered |
| 2 Pediatric Dept B | – | –Children's files from this department will be analysed once weekly and medication prescription data will be registered |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Admitted children for medical treatment in two different pediatric departments
Key inclusion criteria (1 listed)
- All admitted children receiving at least one prescribed or OTC medication.
Key exclusion criteria (1 listed)
- All admitted children who do not get a prescribed or OTC medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptive use of medications
Time frame: One year
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 11 Jun 2013.
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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.
Norberto Krivoy, MD principal investigator
Rambam Health Care Campus
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 Infectious Diseases and Metabolic Diseases, run by Rambam Health Care Campus 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: finished, as of the sponsor's last update on 11 Jun 2013. 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 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?
Descriptive use of medications (time frame: One year). 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 11 Jun 2013.