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

NCT07320612 — Phase 1, Completed, 160 participants, University of Child Health Sciences and Children's Hospital, Lahore

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07320612
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: none, other
Enrollment	160 (Actual)
Sponsor	University of Child Health Sciences and Children's Hospital, Lahore (Other)
Conditions	Nephrotic Syndrome
Interventions	Azithromycin and steroids, steroids (Drug)
Dates	start 2025-03-08, primary completion 2025-08-08, completion 2025-10-08, first posted 2026-01-06, last updated 2026-01-06
Locations	1 site in Pakistan

-Summary

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

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Group taking Azithromycin and Steroids	Experimental	Drug: 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 Taking steroids	Active comparator	Drug: steroids	80 Children will be assigned group B in which children will be only given standard course of steroids.

Azithromycin and steroids (Drug), also known as Azithromycin: 80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.
steroids (Drug): 80 children will be assigned group B and will be given only standard course of treatment

+Outcome measures

Primary outcomes

Early remission. [14 days]: 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.

Secondary outcomes

Relapse reduction [14 days]: Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids.

+Eligibility

Sex: All, ages: 2 Years to 14 Years, 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

+Locations (1)

Facility	City	Country	Status
UCHS	Lahore, Punjab Province	Pakistan

+Investigators

Dr. Ummara Subhani, MD, Principal investigator, UCHS Lahore