Clinical PharmacistsNCT05002647
Relationship Between the Clinical Pharmacist & Antibiotic Use by Using the Electronic Program
An observational study of Clinical Pharmacists and Electronic Medical Record, run by Alexandria University at 1 site in Egypt.
Trial summary
A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Pharmacists, Electronic Medical Record
- How many people
- 2,601 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2021to 10 Mar 2022
- 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: All patients who administered antimicrobials
Who may be able to join
- All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).
Who cannot join
- Any other cause of hospital admission other than infectious disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Clinical Pharmacist & Antibiotic Use in Selected Infectious Disease Hospitals in El Beheira by Using the Electronic Program, Retrospective Cohort
A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.
Read the detailed description
The role of clinical pharmacist includes :
- a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs.
- Documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (CPC "clinical patient care").
- The clinical pharmacist inspector reviews the data recorded on CPC.
- Conditions
- Clinical Pharmacists, Electronic Medical Record
- Being tested
- NO intervention
- Keywords
- clinical pharmacist, antibiotic consumption, antibiotic use, cost-saving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO interventionOther
There is no intervention
| Study group | Role | What they receive |
|---|---|---|
| exposure group | Data from electronic clinical pharmacist records of two infectious disease hospitals Receives: Other: NO intervention | |
| Non-exposure group A | Data from medical records of the hospital with no clinical pharmacy. Receives: Other: NO intervention | |
| Non-exposure group B | Data from a medical record of the hospital with clinical pharmacy, but the department did not cover by the clinical pharmacy Receives: Other: NO intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial consumption
consumption of antimicrobials (defined daily doses / 100 patient-days)
Measured: 2 years
Days of therapy (DOT)
Number of days of each antimicrobial received for therapy
Measured: 2 years
Length of therapy(LOT)
The number of days a patient takes an antibacterial drug, regardless of the number of different medications
Measured: 2 years
Secondary outcomes (4)
cost savings
(initial treatment cost × days before intervention) - (cost after intervention × days with this treatment),
Measured: 2 years
Mortality rate
in-hospital mortality rate (%)
Measured: 2 years
Antimicrobial resistance
resistance defined as resistance to at least one antimicrobial from the panel for all organisms, and for a subset of organisms belonging to the ESKAPE group (Enterococcus faecium, S. aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa , and Enterobacter spp.
Measured: 2 years
The incidence of adverse reaction of antimicrobial
An unexpected medical problem that happens during treatment with antimicrobial.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start15 Sep 2021
- Primary completion1 Jan 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Clinical PharmacistsStudies 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
- Retrospective
- Enrolment
- 2,601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt
- Responsible party
- Sponsor
- Investigators
- Amira zidane, Principal investigator, Ministry of Health and Population, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002647
- Sponsor's protocol ID
- 14-2021/13
- Status last verified
- Aug 2021
- First submitted
- 7 Aug 2021
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karakonstantis S, Kalemaki D. Antimicrobial overuse and misuse in the community in Greece and link to antimicrobial resistance using methicillin-resistant S. aureus as an example. J Infect Public Health. 2019 Jul-Aug;12(4):460-464. doi: 10.1016/j.jiph.2019.03.017. Epub 2019 Apr 10.
PubMed 30981652Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4.
PubMed 28882725Ourghanlian C, Lapidus N, Antignac M, Fernandez C, Dumartin C, Hindlet P. Pharmacists' role in antimicrobial stewardship and relationship with antibiotic consumption in hospitals: An observational multicentre study. J Glob Antimicrob Resist. 2020 Mar;20:131-134. doi: 10.1016/j.jgar.2019.07.009. Epub 2019 Jul 16.
PubMed 31323427
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Clinical Pharmacist & Antibiotic Use in Selected Infectious Disease Hospitals in El Beheira by Using the Electronic Program, Retrospective Cohort
- ClinicalTrials.gov ID
- NCT05002647
- Acronym / sponsor ID
- 14-2021/13
- Conditions
- Clinical Pharmacists, Electronic Medical Record
- Keywords
- clinical pharmacist, antibiotic consumption, antibiotic use, cost-saving
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,601 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Population, Egypt
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 12 Aug 2021 (actual)
- 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.
A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.
Detailed description
The role of clinical pharmacist includes :
- a check of suitable selection and dosing of antimicrobials according to the diagnosis, type of infection, antimicrobial cultures as possible, comorbidities of patients (renal or hepatic function, etc), adverse effect, and drug interaction with other drugs.
- Documentation of the clinical intervention, cost-saving, adverse effect,, antimicrobial culture and antimicrobial consumption on the electronic program (CPC "clinical patient care").
- The clinical pharmacist inspector reviews the data recorded on CPC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| exposure group | – | Other: NO interventionData from electronic clinical pharmacist records of two infectious disease hospitals |
| Non-exposure group A | – | Other: NO interventionData from medical records of the hospital with no clinical pharmacy. |
| Non-exposure group B | – | Other: NO interventionData from a medical record of the hospital with clinical pharmacy, but the department did not cover by the clinical pharmacy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who administered antimicrobials
Key inclusion criteria (1 listed)
- All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).
Key exclusion criteria (1 listed)
- Any other cause of hospital admission other than infectious disease.
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 |
|---|---|---|
| NO interventionThere is no intervention | Other | Non-exposure group A, Non-exposure group B, exposure group |
Primary outcome
Antimicrobial consumption
Time frame: 2 years
consumption of antimicrobials (defined daily doses / 100 patient-days)
Days of therapy (DOT)
Time frame: 2 years
Number of days of each antimicrobial received for therapy
Length of therapy(LOT)
Time frame: 2 years
The number of days a patient takes an antibacterial drug, regardless of the number of different medications
4 secondary outcomes
cost savings
Time frame: 2 years
Mortality rate
Time frame: 2 years
Antimicrobial resistance
Time frame: 2 years
The incidence of adverse reaction of antimicrobial
Time frame: 2 years
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 27 Dec 2024.
- Background: PubMed 30981652Karakonstantis S, Kalemaki D. Antimicrobial overuse and misuse in the community in Greece and link to antimicrobial resistance using methicillin-resistant S. aureus as an example. J Infect Public Health. 2019 Jul-Aug;12(4):460-464. doi: 10.1016/j.jiph.2019.03.017. Epub 2019 Apr 10.
- Background: PubMed 28882725Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4.
- Background: PubMed 31323427Ourghanlian C, Lapidus N, Antignac M, Fernandez C, Dumartin C, Hindlet P. Pharmacists' role in antimicrobial stewardship and relationship with antibiotic consumption in hospitals: An observational multicentre study. J Glob Antimicrob Resist. 2020 Mar;20:131-134. doi: 10.1016/j.jgar.2019.07.009. Epub 2019 Jul 16.
- 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.
Amira zidane principal investigator
Ministry of Health and Population, Egypt
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 Clinical Pharmacists and Electronic Medical Record, run by Alexandria University at 1 site in Egypt.
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 27 Dec 2024. 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 Egypt. 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?
Antimicrobial consumption (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002647, which also lists 3 linked publications.
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 27 Dec 2024.