- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184103
Acute Post Streptococcal Glomerulonephritis
Clinical Spectrum and Outcome of Acute Post Streptococcal Glomerulonephritis in Children .
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mostafa Shafeek, MD
- Phone Number: 01112110096
- Email: Drmostafashafeek20@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This study will be done on children attending at Assiut University Children Hospital with clinical manifestation of acute post streptococcal glomerulonephritis during one year period .
In addition to meticulous history taking and thorough clinical examination , all the cases will be subjected to the following laboratory investigations :
Complete blood count on admission, urine analysis, blood urea, serum creatinine, serum albumin, serum cholesterol, urine spot protein creatinine ratio, antistreptolysin O , Erythrocyte sedimentation rate , C-reactive protein and serum complement C3 levels on admission and after 8 weeks.
Description
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 .
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients with full recovery or having complication at time of discharge and after 8 week
Time Frame: one year
|
serum complementary test by ELISA
|
one year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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. doi: 10.1186/cc5713.
- Couser WG. Glomerulonephritis. Lancet. 1999 May 1;353(9163):1509-15. doi: 10.1016/S0140-6736(98)06195-9.
- 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. No abstract available.
- 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. doi: 10.1007/s004670050247.
- Barbiano Di Belgiojoso G, Genderini A, Ferrario F. [Post-infectious glomerulonephritis]. G Ital Nefrol. 2003 Mar-Apr;20(2):184-99. Italian.
- Matsukura H, Ohtsuki A, Fuchizawa T, Miyawaki T. Acute poststreptococcal glomerulonephritis mimicking Henoch-Schonlein purpura. Clin Nephrol. 2003 Jan;59(1):64-5. doi: 10.5414/cnp59064. No abstract available.
- Nordstrand A, Norgren M, Holm SE. Pathogenic mechanism of acute post-streptococcal glomerulonephritis. Scand J Infect Dis. 1999;31(6):523-37. doi: 10.1080/00365549950164382.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APSGN
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on PSGN - Post-Streptococcal Glomerulonephritis
-
National Institute of Allergy and Infectious Diseases...Completed
-
University of Cape TownNatal Bioproducts InstituteCompletedSydenham Chorea | Post Streptococcal Movement DisorderSouth Africa
-
Meir Medical CenterCompletedPost Streptococcal Reactive ArthritisIsrael
-
Hillel Yaffe Medical CenterUnknownKidney Scarring Post-Febrile UTIIsrael
-
All Natural Medicine Clinic, LLCRecruitingDepression | Anxiety Disorders | Hepatitis | Insomnia | Gastro Esophageal Reflux | GERD | Glomerulonephritis | Depression, Anxiety | Depression, Bipolar | Sequelae of; Infection | Post Infection Glomerulonephritis | Post-Infectious Peripheral Neuralgia | Post-Infectious Disorder (Disorder) | Post-Infectious Arthritis and other conditionsUnited States
Clinical Trials on anti streptolysin o titre and serum complement test
-
Assiut UniversityCompleted
-
Hamamatsu UniversityCompletedGastric Ulcer | H. Pylori Infection | Duodnal UlcerJapan
-
Andres J. M. FerreriCompletedOcular Adnexal Mucosa-Associated Lymphoid Tissue LymphomaItaly
-
University of RochesterRochester General HospitalCompletedRespiratory InfectionsUnited States
-
Allina Health SystemTerminatedPhysical DisabilityUnited States
-
The First Affiliated Hospital of Xiamen UniversityCompleted
-
Sohag UniversityEnrolling by invitationSystemic Lupus ErythematosusEgypt
-
University Hospital of North NorwayOslo University Hospital; Luxembourg Institute of HealthRecruitingHypersensitivity, Immediate | AllergyNorway
-
Assiut UniversityUnknown
-
University of Turin, ItalyUnknownAttention Deficit-Hyperactivity DisorderItaly