QTc Prolongation, Hyperglycemia, Hypoglycemia
Conditions
Keywords
Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.
Brief 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.
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 Some agents of fluoroquinolones were withdrawn from market.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.
Interventions
DRUGCiprofloxacin 400 MG/200 ML Intravenous Solution
antibiotic
DRUGLevofloxacin 750 MG
antibiotic
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of ciprofloxacin versus levofloxacin on QTc interval | 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 | 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) |
Countries
Egypt
Outcome results
None listed