Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: QTc Prolongation, Hyperglycemia, Hypoglycemia

Treatments: Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution; Drug: Levofloxacin 750 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04456712

ciprofloxacin and levofloxacin

Details and patient eligibility

About

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

Full 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 Some agents of fluoroquinolones were withdrawn from market.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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups

ciprofloxacin for diabetic patients

Experimental group

Description:

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

Treatment:

Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution

levofloxacin for diabetic patients

Experimental group

Description:

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

Treatment:

Drug: Levofloxacin 750 MG

ciprofloxacin for non-diabetic patients

Experimental group

Description:

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

Treatment:

Drug: Ciprofloxacin 400 MG/200 ML Intravenous Solution

levofloxacin for non-diabetic patients

Experimental group

Description:

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

Treatment:

Drug: Levofloxacin 750 MG