Acute Post Streptococcal Glomerulonephritis

PSGN - Post-Streptococcal Glomerulonephritis Clinical Trial

Official title:

Clinical Spectrum and Outcome of Acute Post Streptococcal Glomerulonephritis in Children .

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03184103
• Other study ID #: APSGN
• Status: Not yet recruiting
• Phase: N/A
• First received: June 8, 2017
• Last updated: June 13, 2017
• Start date: June 27, 2017
• Est. completion date: December 27, 2019

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Mostafa Shafeek, MD
• Phone: 01112110096
• Email: Drmostafashafeek20[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Acute post streptococcal glomerulonephritis is an immunologic response of the kidney to infection, characterized by the sudden appearance of edema, hematuria, proteinuria and hypertension . It is essentially a disease of childhood that accounts for approximately 90% of renal disorders in children. The disease occurs especially in children between the ages of 2 and 12 years and young adults, and more often in male than in female .

Description:

Acute post streptococcal glomerulonephritis are caused by group A beta haemolytic streptococci and follow upper airway infections such as pharyngitis or tonsillitis, by 14 to 21 days and 3-6 weeks after skin infection especially in warmer climates .

In recent decades the number of patients with post streptococcal glomerulonephritis has decreased considerably in the United States and Europe industrialized countries. In other parts of the world ,some developing communities. the incidence of post streptococcal glomerulonephritis has remained high. post streptococcal glomerulonephritis is one of the leading cause requiring hospital admissions in children , and it is also an important cause of acute renal failure in developing countries. Though deaths due to this disease are rare, it can cause serious complications such as hypertensive emergency, congestive cardiac failure, renal failure, encephalopathy and retinopathy .

Acute post streptococcal glomerulonephritis can also progress to rapidly progressive glomerulonephritis which is defined as''a syndrome that progresses rapidly within a few weeks or months to renal failure and is accompanied by urinary findings of nephritis.'' The clinical concept of rapidly progressive glomerulonephritis includes various renal diseases that cause renal function to deteriorate over a subacute course. Necrotizing crescentic glomerulonephritis is often observed in histopathological findings .

Acute post streptococcal glomerulonephritis was diagnosed in the presence of :

features of acute nephritic syndrome. evidence of recent streptococcal infection. lower serum complement three levels. Anti streptolysin o titre >200 units/ml was considered as evidence of recent streptococcal infection

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 15 Years

Eligibility

Inclusion Criteria:

• Children in the age groups of 2-15 years. presenting with clinical manifestation of acute nephritic syndrome will be included in the study.

Exclusion Criteria:

• Children having history suggestive of chronic renal and cardiac disease in the past

• Children with congenital renal anomalies .

• Children with clinical manifestation of nephrotic syndrome .

• Children with clinical manifestation of acute nephritic syndrome due to other causes .

Related Conditions & MeSH terms

• Glomerulonephritis
• PSGN - Post-Streptococcal Glomerulonephritis

Intervention

Diagnostic Test:
• anti streptolysin o titre and serum complement test
diagnostic lab test

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (8)

Arimura Y, Muso E, Fujimoto S, Hasegawa M, Kaname S, Usui J, Ihara T, Kobayashi M, Itabashi M, Kitagawa K, Hirahashi J, Kimura K, Matsuo S. Evidence-based clinical practice guidelines for rapidly progressive glomerulonephritis 2014. Clin Exp Nephrol. 2016 Jun;20(3):322-41. doi: 10.1007/s10157-015-1218-8. Review. — View Citation

Arora P, Kher V, Rai PK, Singhal MK, Gulati S, Gupta A. Prognosis of acute renal failure in children: a multivariate analysis. Pediatr Nephrol. 1997 Apr;11(2):153-5. — View Citation

Barbiano Di Belgiojoso G, Genderini A, Ferrario F. [Post-infectious glomerulonephritis]. G Ital Nefrol. 2003 Mar-Apr;20(2):184-99. Review. Italian. — View Citation

Couser WG. Glomerulonephritis. Lancet. 1999 May 1;353(9163):1509-15. Review. — View Citation

Kanjanabuch T, Kittikowit W, Eiam-Ong S. An update on acute postinfectious glomerulonephritis worldwide. Nat Rev Nephrol. 2009 May;5(5):259-69. doi: 10.1038/nrneph.2009.44. Review. — View Citation

Matsukura H, Ohtsuki A, Fuchizawa T, Miyawaki T. Acute poststreptococcal glomerulonephritis mimicking Henoch-Schönlein purpura. Clin Nephrol. 2003 Jan;59(1):64-5. — View Citation

Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. — View Citation

Nordstrand A, Norgren M, Holm SE. Pathogenic mechanism of acute post-streptococcal glomerulonephritis. Scand J Infect Dis. 1999;31(6):523-37. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with full recovery or having complication at time of discharge and after 8 week	serum complementary test by ELISA	one year