Ciprofloxacin Adverse ReactionNCT05916105
Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting
An observational study of Ciprofloxacin Adverse Reaction, run by Damanhour University at 1 site in Egypt.
Trial summary
Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ciprofloxacin Adverse Reaction
- What is being tested?
- Ciprofloxacin Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 151 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2021to 1 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: A total of 151 patients' record indicated for ciprofloxacin were included in the study.
Who may be able to join
- All ciprofloxacin included prescription during the study period.
Who cannot join
- un included ciprofloxacin prescription.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drug Utilization Evaluation Study of Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting: A Cross-Sectional Study
Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use.
Methods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.
Read the detailed description
From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies.
Data Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences.
Study variables:
- age, gender, pregnancy/lactation
- Department/indication
- Dose, Frequency, Duration, Adverse events, Drug interactions.
Data was categorized and analyzed using appropriate software.
- Conditions
- Ciprofloxacin Adverse Reaction
- Being tested
- Ciprofloxacin Tablets
- Keywords
- Ciprofloxacin, Use evaluation, Drug interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin TabletsDrug
Also called Ciprofloxacin
Ciprofloxacin antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | 151 record of Ciprofloxacin Receives: Drug: Ciprofloxacin Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indications
Appropriate Indications of ciprofloxacin (frequency )
Measured: 6 months
ciprofloxacin prescription (frequency )
Number of appropriate ciprofloxacin prescription
Measured: 6 months
adverse events
adverse events occured during ciprofloxacin therapy (frequency )
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 posted23 Jun 2023
- Study start1 Sep 2021
- Primary completion28 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ciprofloxacin Adverse ReactionStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Werida, Damanhour University
- Investigators
- Rehab H Werida, Ass. Prof., Study director, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916105
- Sponsor's protocol ID
- Ciprofloxacin Utilization
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldman MP. Ciprofloxacin drug utilization review and prospective drug use evaluation. DICP. 1990 Jan;24(1):82-6. doi: 10.1177/106002809002400115.
PubMed 2301191Davis R, Markham A, Balfour JA. Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs. 1996 Jun;51(6):1019-74. doi: 10.2165/00003495-199651060-00010.
PubMed 8736621
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Evaluation Study of Ciprofloxacin Utilization and Adverse Events Occurrence in Community Pharmacy Setting: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT05916105
- Acronym / sponsor ID
- Ciprofloxacin Utilization
- Conditions
- Ciprofloxacin Adverse Reaction
- Keywords
- Ciprofloxacin, Use evaluation, Drug interaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 23 Jun 2023 (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.
Background: Ciprofloxacin is a fluoroquinolone that is commonly used to treat a variety of diseases. Ciprofloxacin resistance is rising, resulting in suboptimal patient care. The goal of this study was to evaluate ciprofloxacin use in the community in terms of acceptable prescription, dose, frequency, and duration of use.
Methods: A cross-sectional research was done in Egyptian community pharmacies by community pharmacists. Patients who were administered oral ciprofloxacin during the research period were included.
Detailed description
From September 2021 to February 2022, a cross-sectional, research was undertaken to evaluate ciprofloxacin usage. The investigation was carried out by community pharmacists in seven Egyptian community pharmacies.
Data Collection: data gathered from pharmacy patients' records on a data collection form that included the factors indicated. The General Symptoms Questionnaire, physical examination, and blood testing were used to identify adverse occurrences.
Study variables:
- age, gender, pregnancy/lactation
- Department/indication
- Dose, Frequency, Duration, Adverse events, Drug interactions.
Data was categorized and analyzed using appropriate software.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | – | Drug: Ciprofloxacin Tablets151 record of Ciprofloxacin |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A total of 151 patients' record indicated for ciprofloxacin were included in the study.
Key inclusion criteria (1 listed)
- All ciprofloxacin included prescription during the study period.
Key exclusion criteria (1 listed)
- un included ciprofloxacin prescription.
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 |
|---|---|---|
| Ciprofloxacin TabletsAlso: CiprofloxacinCiprofloxacin antibiotic | Drug | Ciprofloxacin |
Primary outcome
Indications
Time frame: 6 months
Appropriate Indications of ciprofloxacin (frequency )
ciprofloxacin prescription (frequency )
Time frame: 6 months
Number of appropriate ciprofloxacin prescription
adverse events
Time frame: 6 months
adverse events occured during ciprofloxacin therapy (frequency )
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 23 Jun 2023.
- Background: PubMed 2301191Goldman MP. Ciprofloxacin drug utilization review and prospective drug use evaluation. DICP. 1990 Jan;24(1):82-6. doi: 10.1177/106002809002400115.
- Background: PubMed 8736621Davis R, Markham A, Balfour JA. Ciprofloxacin. An updated review of its pharmacology, therapeutic efficacy and tolerability. Drugs. 1996 Jun;51(6):1019-74. doi: 10.2165/00003495-199651060-00010.
- Individual participant dataSharing planned: No
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.
Rehab H Werida, Ass. Prof. study director
Damanhour University
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 Ciprofloxacin Adverse Reaction, run by Damanhour 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 23 Jun 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?
Indications (time frame: 6 months). 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 NCT05916105, which also lists 2 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 23 Jun 2023.