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临床试验/NCT04456712
NCT04456712已完成4 期

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

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Effect of ciprofloxacin versus levofloxacin on QTc interval

研究概览

简要总结

To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.

详细描述

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 Some agents of fluoroquinolones were withdrawn from market.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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

levofloxacin for non-diabetic patients

Experimental

50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours.

干预措施: Levofloxacin 750 MG (Drug)

ciprofloxacin for diabetic patients

Experimental

50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours.

干预措施: Ciprofloxacin 400 MG/200 ML Intravenous Solution (Drug)

levofloxacin for diabetic patients

Experimental

50 diabetic patients received intravenous levofloxacin 750mg/24 hours.

干预措施: Levofloxacin 750 MG (Drug)

ciprofloxacin for non-diabetic patients

Experimental

50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.

干预措施: Ciprofloxacin 400 MG/200 ML Intravenous Solution (Drug)

结局指标

主要结局

Effect of ciprofloxacin versus levofloxacin on QTc interval

时间窗: 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

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Abd El-Hamed Saad Rezk

clinical pharmacist

Beni-Suef University

研究点 (1)

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