Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

QTc Prolongation, Hyperglycemia, Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456712
• Other study ID #: ciprofloxacin and levofloxacin
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: June 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 Some agents of fluoroquinolones were withdrawn from market.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperglycemia
• Hypoglycemia
• QTc Prolongation, Hyperglycemia, Hypoglycemia

Intervention

Drug:
• Ciprofloxacin 400 MG/200 ML Intravenous Solution
antibiotic
• Levofloxacin 750 MG
antibiotic

Locations

Country	Name	City	State
Egypt	Beni-Suef university hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

González M C, Rosales C R, Pavez D, Fuenzalida LM, Soto A, Pérez R, Pérez 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. — View Citation

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. Review. Spanish. — View Citation

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. Review. — View Citation

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). pii: E104. doi: 10.3390/antibiotics8030104. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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