Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome

Phase 1CompletedNCT07320612

University of Child Health Sciences and Children's Hospital, Lahore160 enrolled

Overview

To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome

It is a randomized controlled trial. Total 160 children meeting inclusion criteria will be included in the study. Selected children will be divided into 2 groups. one group will be given Azithromycin at 10mg/kg/day (1 dose per day) for 3 days along with standard course of steroids. 2nd group will be given standard course of treatment. All patients will be followed up for 1 month and remission will be noted. All data will be collected through specially designed performa. Patient's safety and Efficacy of drug in Achieving early Remission will be closely monitored.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Nephrotic Syndrome

Interventions

Azithromycin and steroidsDRUG

80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.

steroidsDRUG

80 children will be assigned group B and will be given only standard course of treatment

Eligibility

Sex: ALLMin age: 2 YearsMax age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children age 2 to 14 years * Both genders * Children having primary nephrotic syndrome Exclusion Criteria: * Children with steroid resistant nephrotic syndrome * Children with secondary causes of nephrotic syndrome * Recent use of azithromycin during last 4 weeks * Severe systemic infection requiring antibiotics * Chronic liver disease Prolong QT Interval or history of cardiac arythmias

Locations (1)

UCHS

Lahore, Punjab Province, Pakistan

Outcomes

Primary Outcomes

Early remission.

This study will make an impact on understanding the effectiveness and safety of azithromycin in children regain early remission. It will be classified as either complete or partial remission. Complete remission will be indicated as negative or having trace proteinuria and will be measured with the help of early morning urine dipstick test for proteinuria for 3 consecutive days, serum albumin level of more than 2.5g/dl and resolution of edema. Partial remission will be defined as serum albumin level of more than 2.5g/dl but with persistent proteinuria. Early Remission and relapse will be presented as frequency and percentage. Both groups will be compared for early remission by chi square test.

Time frame: 14 days

Secondary Outcomes

Relapse reduction

Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.

Time frame: 14 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.