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

University of Child Health Sciences and Children's Hospital, Lahore

Status and phase: Completed; Phase 1

Conditions: Nephrotic Syndrome

Treatments: Drug: Azithromycin and steroids; Drug: steroids

Study type: Interventional

Funder types: Other

Identifiers

NCT07320612

08-03-2025Approved by UCHS

Details and patient eligibility

About

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

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Group taking Azithromycin and Steroids

Experimental group

Description:

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.

Treatment:

Drug: Azithromycin and steroids

Group Taking steroids

Active Comparator group

Description:

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

Treatment:

Drug: steroids