Critical IllnessNCT04931914
Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics
An observational study of Critical Illness, run by University of Alexandria at 1 site in Egypt.
Trial summary
adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Clinical pharmacy sharing in the patient care regimen
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Jan 2020to 25 Dec 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the information including the age, gender, comorbidity (presented as Charlson comorbidity index score ), surgical procedure done, patients' temperature, white blood cells count, type of infection (e.g., pneumonia, wound infection, Urinary tract infection,…..), prescribed antibiotics regimen either they will use empirical or based on cultures, results of culture sensitivity tests, length of stay, and mortality of patients
Who may be able to join
- all admitted patients to the ICU between age 18-80 years old
Who cannot join
- Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study.
- Pediatric patients weighted less than kilograms.
Trial locations and contacts
1 site in 1 country.
About this study
adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.
Read the detailed description
During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.
- Conditions
- Critical Illness
- Being tested
- Clinical pharmacy sharing in the patient care regimen
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical pharmacy sharing in the patient care regimenOther
antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.
| Study group | Role | What they receive |
|---|---|---|
| Group c | Patients admitted from June 9, 2020 to june 31, 2021. Receives: Other: Clinical pharmacy sharing in the patient care regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotics consumption
consumption will be counted as number of defined daily doses (DDD), expressed as DDD per 100 patient-days
Measured: 1 year
Average length of stay
the average number of days that patients spent in SICU.
Measured: 1 year
Mortality rate
The number of deaths of patients admitted to SICU, divided by the number of admissions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start4 Jan 2020
- Primary completion5 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mabrouk Ibrahim, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931914
- Sponsor's protocol ID
- 203
- Status last verified
- Nov 2022
- First submitted
- 29 May 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics
- ClinicalTrials.gov ID
- NCT04931914
- Acronym / sponsor ID
- 203
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- 4 Jan 2020 (actual)
- Primary completion
- 5 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 18 Jun 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.
adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.
Detailed description
During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group c | – | Other: Clinical pharmacy sharing in the patient care regimenPatients admitted from June 9, 2020 to june 31, 2021. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the information including the age, gender, comorbidity (presented as Charlson comorbidity index score ), surgical procedure done, patients' temperature, white blood cells count, type of infection (e.g., pneumonia, wound infection, Urinary tract infection,…..), prescribed antibiotics regimen either they will use empirical or based on cultures, results of culture sensitivity tests, length of stay, and mortality of patients
Key inclusion criteria (1 listed)
- all admitted patients to the ICU between age 18-80 years old
Key exclusion criteria (2 listed)
- Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study.
- Pediatric patients weighted less than kilograms.
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 pharmacy sharing in the patient care regimenantibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist. | Other | Group c |
Primary outcome
Antibiotics consumption
Time frame: 1 year
consumption will be counted as number of defined daily doses (DDD), expressed as DDD per 100 patient-days
Average length of stay
Time frame: 1 year
the average number of days that patients spent in SICU.
Mortality rate
Time frame: 1 year
The number of deaths of patients admitted to SICU, divided by the number of admissions.
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 Nov 2022.
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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.
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 Critical Illness, run by University of Alexandria 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 2 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 Nov 2022. 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?
Antibiotics consumption (time frame: 1 year). 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?
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 Nov 2022.