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

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

Study Overview

• Status: Completed
• Conditions: Nephrotic Syndrome
• Intervention / Treatment: Drug: Azithromycin and steroids; Drug: steroids

Detailed Description

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
• Enrollment (Actual): 160
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Lahore, Punjab Province, Pakistan, 54600
      • UCHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group taking Azithromycin and Steroids; 80 Children will be assigned group A in which children will be given Azithromycin at 10mg /kg/day Per oral along with standard course of treatment.	Drug: Azithromycin and steroids; 80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.; Other Names: Azithromycin
Active Comparator: Group Taking steroids; 80 Children will be assigned group B in which children will be only given standard course of steroids.	Drug: steroids; 80 children will be assigned group B and will be given only standard course of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse reduction	Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.	14 days

Collaborators and Investigators

• Sponsor: University of Child Health Sciences and Children's Hospital, Lahore
• Investigators: Principal Investigator: Dr. Ummara Subhani, MD, UCHS Lahore

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2025
• Primary Completion (Actual): August 8, 2025
• Study Completion (Actual): October 8, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Nephrosis; Nephrotic Syndrome; Organic Chemicals; Polycyclic Compounds; Fused-Ring Compounds; Macrolides; Lactones; Erythromycin; Polyketides; Azithromycin; Steroids
• Other Study ID Numbers: 08-03-2025Approved by UCHS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No