QTc Prolongation, Hyperglycemia, HypoglycemiaPhase 4NCT04456712
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia
A Phase 4 study testing Ciprofloxacin 400 MG/200 ML Intravenous Solution and Levofloxacin 750 MG in people with QTc Prolongation, Hyperglycemia, Hypoglycemia, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- QTc Prolongation, Hyperglycemia, Hypoglycemia
- What is being tested?
- Ciprofloxacin 400 MG/200 ML Intravenous Solution and Levofloxacin 750 MG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2018to 30 Dec 2018
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient (male, female)
- age from 18 to 70 years .
- Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs
- Wiling to participate whole clinical trial periods
Who cannot join
- Younger than 18 years or older than 70 years.
- Has prolonged QTc before receiving therapy.
- With a history of heart diseases.
- Received class IA or III antiarrhythmic agents.
- Received macrolide antibiotics.
- With a history of quinolone allergy.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia in Diabetic and Non-Diabetic Patients.
To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.
Read the detailed description
Fluoroquinolones represent an important class of antibacterial drug and they are used worldwide.Fluoroquinolones are classified into generations according to the spectrum of antimicrobial activities that targeted them.Fluoroquinolones may cause several side effects as tendon rupture, central nervous toxicity, cardiovascular toxicity, gastrointestinal toxicity, phototoxicity, disrupted glucose metabolism, skin disorders and hypersensitivity. Ciprofloxacin, a second generation fluoroquinolone, is one of the most successful and widely used compounds of fluoroquinolone. On the other hand, levofloxacin is a third generation fluoroquinolone.
Diabetes mellitus (DM) is chronic disease and a serious of metabolic disorder associated with the presence of hyperglycemia due to partial or complete insulin deficiency. Diabetes mellitus is a major risk factor for cardiovascular diseases.
Fluoroquinolone class is associated with cardiac side effects as QTc prolongation. Some agents of fluoroquinolones were withdrawn from market. However, cardiac adverse effects has been developed with fluoroquinolones still in market. Members of fluoroquinolones class have different effects on QT interval. The US FDA suggested that the risk and benefits ratio of fluoroquinolones should be taken into consideration.
In addition to hyperglycemia events are more common with fluoroquinolones than with other classes of antibiotics. The food and drug administration (FDA) confirmed the current warning that fluoroquinolones may cause decrease in blood sugar especially in diabetic patients. However, other study proved that fluoroquinolones may cause dysglycemic events in diabetic and non-diabetic patients.
- Being tested
- Ciprofloxacin 400 MG/200 ML Intravenous Solution, Levofloxacin 750 MG
- Keywords
- Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ciprofloxacin 400 MG/200 ML Intravenous SolutionDrug
antibiotic
Levofloxacin 750 MGDrug
antibiotic
| Study group | Role | What they receive |
|---|---|---|
| ciprofloxacin for diabetic patients | Experimental | 50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours. Receives: Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution |
| levofloxacin for diabetic patients | Experimental | 50 diabetic patients received intravenous levofloxacin 750mg/24 hours. Receives: Drug: Levofloxacin 750 MG |
| ciprofloxacin for non-diabetic patients | Experimental | 50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours. Receives: Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution |
| levofloxacin for non-diabetic patients | Experimental | 50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours. Receives: Drug: Levofloxacin 750 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ciprofloxacin versus levofloxacin on QTc interval
change in QTc interval (QTc prolongation)
Measured: before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation
Effect of ciprofloxacin versus levofloxacin on fasting blood glucose
change in fasting blood glucose (dysglycemia)
Measured: before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start1 Jun 2018
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for QTc Prolongation, Hyperglycemia, HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- fifty diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty diabetic patients received intravenous ciprofloxacin 400mg/12 hours. fifty non-diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Abd El-Hamed Saad Rezk, Beni-Suef University
- Investigators
- Ahmed A Elberry, professor, Study director, Faculty of medicine, Beni-Suef university, Beni-Suef, EgyptHazem S Hussein, MD, Study director, Faculty of medicine, Beni-Suef university, Beni-Suef, EgyptRaghda R Sayed, PhD, Study director, Faculty of pharmacy, Beni-Suef university, Beni-Suef, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456712
- Sponsor's protocol ID
- ciprofloxacin and levofloxacin
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mathews B, Thalody AA, Miraj SS, Kunhikatta V, Rao M, Saravu K. Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility. Antibiotics (Basel). 2019 Jul 27;8(3):104. doi: 10.3390/antibiotics8030104.
PubMed 31357640Lu ZK, Yuan J, Li M, Sutton SS, Rao GA, Jacob S, Bennett CL. Cardiac risks associated with antibiotics: azithromycin and levofloxacin. Expert Opin Drug Saf. 2015 Feb;14(2):295-303. doi: 10.1517/14740338.2015.989210. Epub 2014 Dec 10.
PubMed 25494485Granados J, Ceballos M, Amariles P. [Hypo or hyperglycemia associated with fluoroquinolone use]. Rev Med Chil. 2018 May;146(5):618-626. doi: 10.4067/s0034-98872018000500618. Spanish.
PubMed 30148925Gonzalez M C, Rosales C R, Pavez D, Fuenzalida LM, Soto A, Perez R, Perez J, Araos R, Pinto ME. [Safety of fluoroquinolones: risks usually forgotten for the clinician]. Rev Chilena Infectol. 2017 Dec;34(6):577-582. doi: 10.4067/S0716-10182017000600577. Spanish.
PubMed 29488552
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia in Diabetic and Non-Diabetic Patients.
- ClinicalTrials.gov ID
- NCT04456712
- Acronym / sponsor ID
- ciprofloxacin and levofloxacin
- Keywords
- Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 2 Jul 2020 (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.
To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.
Detailed description
Fluoroquinolones represent an important class of antibacterial drug and they are used worldwide.Fluoroquinolones are classified into generations according to the spectrum of antimicrobial activities that targeted them.Fluoroquinolones may cause several side effects as tendon rupture, central nervous toxicity, cardiovascular toxicity, gastrointestinal toxicity, phototoxicity, disrupted glucose metabolism, skin disorders and hypersensitivity. Ciprofloxacin, a second generation fluoroquinolone, is one of the most successful and widely used compounds of fluoroquinolone. On the other hand, levofloxacin is a third generation fluoroquinolone.
Diabetes mellitus (DM) is chronic disease and a serious of metabolic disorder associated with the presence of hyperglycemia due to partial or complete insulin deficiency. Diabetes mellitus is a major risk factor for cardiovascular diseases.
Fluoroquinolone class is associated with cardiac side effects as QTc prolongation. Some agents of fluoroquinolones were withdrawn from market. However, cardiac adverse effects has been developed with fluoroquinolones still in market. Members of fluoroquinolones class have different effects on QT interval. The US FDA suggested that the risk and benefits ratio of fluoroquinolones should be taken into consideration.
In addition to hyperglycemia events are more common with fluoroquinolones than with other classes of antibiotics. The food and drug administration (FDA) confirmed the current warning that fluoroquinolones may cause decrease in blood sugar especially in diabetic patients. However, other study proved that fluoroquinolones may cause dysglycemic events in diabetic and non-diabetic patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- fifty diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty diabetic patients received intravenous ciprofloxacin 400mg/12 hours. fifty non-diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.
| Arm | Type | Receives |
|---|---|---|
| ciprofloxacin for diabetic patients | Experimental | Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours. |
| levofloxacin for diabetic patients | Experimental | Drug: Levofloxacin 750 MG50 diabetic patients received intravenous levofloxacin 750mg/24 hours. |
| ciprofloxacin for non-diabetic patients | Experimental | Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours. |
| levofloxacin for non-diabetic patients | Experimental | Drug: Levofloxacin 750 MG50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patient (male, female)
- age from 18 to 70 years .
- Be able to give an informed consent form after understanding for reasonable explanation of clinical trial's purpose, contents and characteristics of clinical drugs
- Wiling to participate whole clinical trial periods
Key exclusion criteria (7 listed)
- Younger than 18 years or older than 70 years.
- Has prolonged QTc before receiving therapy.
- With a history of heart diseases.
- Received class IA or III antiarrhythmic agents.
- Received macrolide antibiotics.
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 400 MG/200 ML Intravenous Solutionantibiotic | Drug | ciprofloxacin for diabetic patients, ciprofloxacin for non-diabetic patients |
| Levofloxacin 750 MGantibiotic | Drug | levofloxacin for diabetic patients, levofloxacin for non-diabetic patients |
Primary outcome
Effect of ciprofloxacin versus levofloxacin on QTc interval
Time frame: before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation
change in QTc interval (QTc prolongation)
Effect of ciprofloxacin versus levofloxacin on fasting blood glucose
Time frame: before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation
change in fasting blood glucose (dysglycemia)
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 2 Jul 2020.
- Background: PubMed 31357640Mathews B, Thalody AA, Miraj SS, Kunhikatta V, Rao M, Saravu K. Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility. Antibiotics (Basel). 2019 Jul 27;8(3):104. doi: 10.3390/antibiotics8030104.
- Background: PubMed 25494485Lu ZK, Yuan J, Li M, Sutton SS, Rao GA, Jacob S, Bennett CL. Cardiac risks associated with antibiotics: azithromycin and levofloxacin. Expert Opin Drug Saf. 2015 Feb;14(2):295-303. doi: 10.1517/14740338.2015.989210. Epub 2014 Dec 10.
- Background: PubMed 30148925Granados J, Ceballos M, Amariles P. [Hypo or hyperglycemia associated with fluoroquinolone use]. Rev Med Chil. 2018 May;146(5):618-626. doi: 10.4067/s0034-98872018000500618. Spanish.
- Background: PubMed 29488552Gonzalez M C, Rosales C R, Pavez D, Fuenzalida LM, Soto A, Perez R, Perez J, Araos R, Pinto ME. [Safety of fluoroquinolones: risks usually forgotten for the clinician]. Rev Chilena Infectol. 2017 Dec;34(6):577-582. doi: 10.4067/S0716-10182017000600577. Spanish.
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.
Ahmed A Elberry, professor study director
Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt
Hazem S Hussein, MD study director
Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt
Raghda R Sayed, PhD study director
Faculty of pharmacy, Beni-Suef university, Beni-Suef, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin 400 MG/200 ML Intravenous Solution and Levofloxacin 750 MG in people with QTc Prolongation, Hyperglycemia, Hypoglycemia, run by Beni-Suef 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 4 inclusion and 7 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 2 Jul 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of ciprofloxacin versus levofloxacin on QTc interval (time frame: before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation). The study lists 2 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 NCT04456712, which also lists 4 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 2 Jul 2020.