Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Some agents of fluoroquinolones were withdrawn from market.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.

Official Title
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Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia in Diabetic and Non-Diabetic Patients.

Conditions
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QTc Prolongation, Hyperglycemia, Hypoglycemia

Intervention / Treatment
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* Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution
* Drug: Levofloxacin 750 MG


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ciprofloxacin for diabetic patients<br>50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours. | Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution<br>* antibiotic<br>|
| Experimental: levofloxacin for diabetic patients<br>50 diabetic patients received intravenous levofloxacin 750mg/24 hours. | Drug: Levofloxacin 750 MG<br>* antibiotic<br>|
| Experimental: ciprofloxacin for non-diabetic patients<br>50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours. | Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution<br>* antibiotic<br>|
| Experimental: levofloxacin for non-diabetic patients<br>50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours. | Drug: Levofloxacin 750 MG<br>* antibiotic<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.