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To compare efficacy and safety of Azithromycin versus control in children with steroid sensitive nephrotic syndrome
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group taking Azithromycin and Steroids | Experimental | 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 | 80 Children will be assigned group B in which children will be only given standard course of steroids. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin and steroids | Drug | 80 children will be assigned group A and children will be given Azithromycin along with standard course of steroids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early remission. | 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse reduction | Lower the frequency of relapses to prevent complications and minimise exposure to drugs like steroids. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Ummara Subhani, MD | UCHS Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCHS | Lahore | Punjab Province | 54600 | Pakistan |
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| ID | Term |
|---|---|
| D009404 | Nephrotic Syndrome |
| ID | Term |
|---|---|
| D009401 | Nephrosis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D013256 | Steroids |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| steroids | Drug | 80 children will be assigned group B and will be given only standard course of treatment |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Organic Chemicals |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |