Infection, BacterialNCT05223400
Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital
An observational study of Infection, Bacterial, run by Alexandria University at 1 site in Egypt.
Trial summary
Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infection, Bacterial
- What is being tested?
- Clindamycin Injection
- Type of treatment
- Injection or infusion
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Apr 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to critical care units and on clindamycin emperical therapy .
Who may be able to join
- Adults 18 years old or more .
- Patients on clindamycin as an empirical treatment.
- Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.
Who cannot join
- Children (less than 18 years old)
- Patients started clindamycin as a defenitive treatment (based on microbiological culture results).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital
Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.
- Conditions
- Infection, Bacterial
- Being tested
- Clindamycin Injection
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin InjectionDrug
it is a clindamycin use evaluation study
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions
appropriateness of clindamycin indication will be determined according to IDSA guidelines.
Measured: 1 month
Secondary outcomes (5)
the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions
duplication of therapy means prescribing of clindamycin concurrently with another antibiotic to target the same microorganism.
Measured: 1 month
the number of patients who had diarrhea as a main side effect of clindamycin
diarrhea is a main side effect of clindamycin so in the study the number of patients who had diarrhea will be counted during the retrospective observation of all prescriptions
Measured: 1 month
the number of patients who had severe drug interactions with clindamycin
in the study the number of patients who severe clindamycin drugs interactions will be counted during the retrospective observation of all prescriptions
Measured: 1 month
Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.
Defined daily doses measurement of a drug is an indicator put by WHO , it indicates the consumption of this drug in a hospital or a department and defined daily doses per 1000 patients days indicates the consumption of this drug in relation to the total number of patients in a certain period of time.
Measured: 1 month
to calculate the total cost of clindamycin.
The cost of clindamycin treatment courses of all patients will be calculated in the Egyptian pound
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start1 Mar 2022
- Primary completion1 Apr 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BacterialStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Shaker, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223400
- Sponsor's protocol ID
- 0305292
- Status last verified
- Feb 2023
- First submitted
- 6 Jan 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital
- ClinicalTrials.gov ID
- NCT05223400
- Acronym / sponsor ID
- 0305292
- Conditions
- Infection, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 4 Feb 2022 (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.
Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to critical care units and on clindamycin emperical therapy .
Key inclusion criteria (3 listed)
- Adults 18 years old or more .
- Patients on clindamycin as an empirical treatment.
- Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.
Key exclusion criteria (2 listed)
- Children (less than 18 years old)
- Patients started clindamycin as a defenitive treatment (based on microbiological culture results).
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 |
|---|---|---|
| Clindamycin Injectionit is a clindamycin use evaluation study | Drug | – |
Primary outcome
the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions
Time frame: 1 month
appropriateness of clindamycin indication will be determined according to IDSA guidelines.
5 secondary outcomes
the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions
Time frame: 1 month
the number of patients who had diarrhea as a main side effect of clindamycin
Time frame: 1 month
the number of patients who had severe drug interactions with clindamycin
Time frame: 1 month
Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.
Time frame: 1 month
to calculate the total cost of clindamycin.
Time frame: 1 month
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 3 Feb 2023.
- Individual participant dataSharing planned: Yes
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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 Infection, Bacterial, 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 3 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 3 Feb 2023. 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?
the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions (time frame: 1 month). 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 3 Feb 2023.