Nephrotic Syndrome
Conditions
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.
Interventions
DRUGAzithromycin and steroids
80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids.
DRUGsteroids
80 children will be assigned group B and will be given only standard course of treatment
Sponsors
University of Child Health Sciences and Children's Hospital, Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Relapse reduction | 14 days | Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids. |
Countries
Pakistan
Outcome results
None listed