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To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.
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 Some agents of fluoroquinolones were withdrawn from market.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ciprofloxacin for diabetic patients | Experimental | 50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours. |
|
| levofloxacin for diabetic patients | Experimental | 50 diabetic patients received intravenous levofloxacin 750mg/24 hours. |
|
| ciprofloxacin for non-diabetic patients | Experimental | 50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours. |
|
| levofloxacin for non-diabetic patients | Experimental | 50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin 400 MG/200 ML Intravenous Solution | Drug | antibiotic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of ciprofloxacin versus levofloxacin on QTc interval | change in QTc interval (QTc prolongation) | 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) | before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed A Elberry, professor | Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt | Study Director |
| Hazem S Hussein, MD | Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt | Study Director |
| Raghda R Sayed, PhD | Faculty of pharmacy, Beni-Suef university, Beni-Suef, Egypt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef university hospital | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31357640 | Background | 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. | |
| 25494485 | Background | Lu 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 6, 2020 | |
| Reset | Jul 20, 2020 | |
| Release | Jul 20, 2020 | |
| Reset | Aug 4, 2020 | |
| Release | Aug 22, 2020 | |
| Reset | Sep 11, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2020 | Jul 20, 2020 | |||
| Jul 20, 2020 |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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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.
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| Levofloxacin 750 MG | Drug | antibiotic |
|
| 30148925 | Background | Granados 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. |
| 29488552 | Background | Gonzalez 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. |
| Aug 4, 2020 |
| Aug 22, 2020 | Sep 11, 2020 |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D015242 | Ofloxacin |