The Effect of Azithromycin Use on Conduction System of Heart in COVID-19 Positive Children

NCT04699097 | Completed

• 1 other identifier: 139
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Azithromycin (AZ) is used in the pediatric group in COVID-19 diseas. It has been reported to cause prolongation in the QT interval in adult age group. The aim of this study is to evaluate the effect of AZ on ventricular repolarization in COVID-19 positive pediatric patients. METHOD The study was conducted prospectively in July-August 2020. COVID-19 pediatric patients who received AZ treatment were included in the study. ECG was obtained before treatment and on the 1st, 3rd and 5th days after the treatment. Measurements were made with Image J program®. QTmax, QTmin, Tp-emax, Tp-emin intervals were measured. QTcmax, QTcmin, Tp-ecmax, Tp-ecmin, QTcd, Tp-ecd, and QTc / Tp-ec ratios were calculated with Bazett formula.

Conditions

Azithromycin Adverse Reaction; Covid19; Long QT Syndrome

Outcome Measures

Primary Outcomes (1)

• Effect of azitromycin on ventricle repolarization

  In the superficial ECG, the QTc, Tp-Tec intervals and Tp-Tec / QTc ratios represent ventricular repolarization. QTc measurement above 0.45 sec is a risk factor for malignant arrhythmia. The significant increase in these intervals and rates compared to previous measurements indicates an increased risk of malignant arrhythmia.

  Before treatment-5th day of treatment

Study Arms (1)

azytromycin

children who recieved azithromycin due to COVID 19 infection

Drug: Azithromycin

Interventions

Azithromycin DRUG

250 mg tablet, 5 ml / 200 mg 30 ml suspension

azytromycin

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children who recieved oral azithromycin therapy due to COVID 19 infection

You may qualify if:

• PCR positive COVID-19 patients
• Age\<18 yearts
• Minimum 3 days oral Azithromycin therapy
• At least one ECG before and after treatment

You may not qualify if:

• parasitic ECG
• not having at least 1 ECG before or after treatment
• taking drugs other than hydroxychloroquine to prolong the QT interval

Sponsors & Collaborators

• Kayseri City Hospital: lead

Study Sites (1)

Süleyman Sunkak

Kayseri, In the USA Or Canada, Please Select..., (554) 217-68, Turkey (Türkiye)

Location

Related Publications (4)

• McMullan BJ, Mostaghim M. Prescribing azithromycin. Aust Prescr. 2015 Jun;38(3):87-9. doi: 10.18773/austprescr.2015.030. Epub 2015 Jun 1.

  PMID: 26648627 BACKGROUND

• Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.

  PMID: 32205204 BACKGROUND

• Schwartz RA, Suskind RM. Azithromycin and COVID-19: Prompt early use at first signs of this infection in adults and children, an approach worthy of consideration. Dermatol Ther. 2020 Jul;33(4):e13785. doi: 10.1111/dth.13785. Epub 2020 Jul 12.

  PMID: 32510734 BACKGROUND

• Dogan U, Yavas G, Tekinalp M, Yavas C, Ata OY, Ozdemir K. Evaluation of the acute effect of palonosetron on transmural dispersion of myocardial repolarization. Eur Rev Med Pharmacol Sci. 2012 Apr;16(4):462-8.

  PMID: 22696873 BACKGROUND

MeSH Terms

Conditions

COVID-19; Long QT Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 7, 2021
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)