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Completed

NCT Number: NCT04456712

Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beni-Suef university hospital

Cairo, Egypt

About this study

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 Some agents of fluoroquinolones were withdrawn from market.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ciprofloxacin 400 MG/200 ML Intravenous Solution

Drug

antibiotic

Levofloxacin 750 MG

Drug

antibiotic

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.