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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-08

Study Completion Date

2025-10-08

Brief Summary

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

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Detailed Description

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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.

Conditions

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Nephrotic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Azithromycin and steroids

Intervention Type DRUG

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

Group Taking steroids

80 Children will be assigned group B in which children will be only given standard course of steroids.

Group Type ACTIVE_COMPARATOR

steroids

Intervention Type DRUG

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

Interventions

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Azithromycin and steroids

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

Intervention Type DRUG

steroids

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

Intervention Type DRUG

Other Intervention Names

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Azithromycin

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes