Efficacy And Safety Of Azithromycin To Achieve Remissionin In Children With Steroid Sensitive Nephrotic Syndrome
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Early remission.
Overview
Brief Summary
To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 14 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Azithromycin and steroids (Drug)
Group Taking steroids
80 Children will be assigned group B in which children will be only given standard course of steroids.
Intervention: steroids (Drug)
Outcomes
Primary Outcomes
Early remission.
Time Frame: 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)
Investigators
Ummara Subhani
Principal investigator
University of Child Health Sciences and Children's Hospital, Lahore