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Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

Primary Purpose

QTc Prolongation, Hyperglycemia, Hypoglycemia

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ciprofloxacin 400 MG/200 ML Intravenous Solution
Levofloxacin 750 MG
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for QTc Prolongation, Hyperglycemia, Hypoglycemia focused on measuring Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beni-Suef university hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ciprofloxacin for diabetic patients

levofloxacin for diabetic patients

ciprofloxacin for non-diabetic patients

levofloxacin for non-diabetic patients

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Effect of ciprofloxacin versus levofloxacin on QTc interval
change in QTc interval (QTc prolongation)
Effect of ciprofloxacin versus levofloxacin on fasting blood glucose
change in fasting blood glucose (dysglycemia)

Secondary Outcome Measures

Full Information

First Posted
June 30, 2020
Last Updated
June 30, 2020
Sponsor
Beni-Suef University
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1. Study Identification

Unique Protocol Identification Number
NCT04456712
Brief Title
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia
Official Title
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia in Diabetic and Non-Diabetic Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
QTc Prolongation, Hyperglycemia, Hypoglycemia
Keywords
Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ciprofloxacin for diabetic patients
Arm Type
Experimental
Arm Description
50 diabetic patients received intravenous ciprofloxacin 400mg/12 hours.
Arm Title
levofloxacin for diabetic patients
Arm Type
Experimental
Arm Description
50 diabetic patients received intravenous levofloxacin 750mg/24 hours.
Arm Title
ciprofloxacin for non-diabetic patients
Arm Type
Experimental
Arm Description
50 non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.
Arm Title
levofloxacin for non-diabetic patients
Arm Type
Experimental
Arm Description
50 non-diabetic patients received intravenous levofloxacin 750mg/24 hours.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin 400 MG/200 ML Intravenous Solution
Intervention Description
antibiotic
Intervention Type
Drug
Intervention Name(s)
Levofloxacin 750 MG
Intervention Description
antibiotic
Primary Outcome Measure Information:
Title
Effect of ciprofloxacin versus levofloxacin on QTc interval
Description
change in QTc interval (QTc prolongation)
Time Frame
before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation
Title
Effect of ciprofloxacin versus levofloxacin on fasting blood glucose
Description
change in fasting blood glucose (dysglycemia)
Time Frame
before starting antibiotic, after 24 hours, 72 hours from the first dose and after 72 hours from antibiotic cessation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed A Elberry, professor
Organizational Affiliation
Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hazem S Hussein, MD
Organizational Affiliation
Faculty of medicine, Beni-Suef university, Beni-Suef, Egypt
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Raghda R Sayed, PhD
Organizational Affiliation
Faculty of pharmacy, Beni-Suef university, Beni-Suef, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Beni-Suef university hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
31357640
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):104. doi: 10.3390/antibiotics8030104.
Results Reference
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PubMed Identifier
25494485
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.
Results Reference
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PubMed Identifier
30148925
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. Spanish.
Results Reference
background
PubMed Identifier
29488552
Citation
Gonzalez M C, Rosales C R, Pavez D, Fuenzalida LM, Soto A, Perez R, Perez 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.
Results Reference
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Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

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