A Phase 3 interventional study of Dexamethasone Oral and Placebo in Urinary Tract Infections in Children, Dexamethasone and Kidney Scarring, sponsored by Hamad Medical Corporation. Recruiting at 1 site in Qatar. Open to participants aged 2 Months to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Hamad Medical Corporation · Phase 3, Interventional, and Prevention
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts 5 to 14% of emergency department visits Formation of renal scarring in children has been associated with serious complications as hypertension, preeclampsia, and end stage renal failure in young age . So, this study aims to determine whether dexamethasone reduces the renal scarring in children will be treated with antibiotics for acute pyelonephritis.
investigators propose to conduct a multi center, randomized, placebo-controlled, double-blind clinical trial, that will evaluate the efficacy of dexamethasone (0.3 mg/kg every 12 hours per day orally for 3 days) in preventing renal scarring in young febrile children (2 months to 14 years) with a first-diagnosed UTI. 120 Participants will be enrolled over a 3-year period from 6 sites.
Urinary tract infection (UTI) is the most frequently occurring serious bacterial infection in young children and accounts for 5 to 14% of emergency department visits. UTIs can be divided into asymptomatic bacteriuria, cystitis, and acute pyelonephritis (APN ). The APN is associated with an increased risk of renal damage, acquired through renal scarring. Which is a consequence of the inflammatory and immune response that aim to eradicate the bacteria involved in the UTI.
Parenchymal infection can be solved, but there are a number of poorly understood factors that may perpetuate inflammation, and this would promote the formation of scarring. One of the most relevant factors involved in formation of renal scarring is the production of inflammatory mediators (complement proteins, bactericidal peptides, cytokines , chemokines, ). hence, the use of anti-inflammatory drugs may prevent the release of these mediators and the formation of permanent renal scarring. Renal scarring in childhood has been associated with serious complications as hypertension, preeclampsia, and ESRD in young age.
Current treatment of children with UTI has focused on the treatment of vesicoureteral reflux (VUR) and on the early treatment of UTI with antibiotics. Although the presence of VUR increases the likelihood of bacteria gaining access to the kidney, correction of VUR is not sufficient to prevent scarring. Renal scarring frequently occurs in children who do not have VUR, and early diagnosis and treatment of children with VUR is not associated with a reduction in the incidence of end-stage renal disease. Similarly, early antibiotic therapy is necessary, but it is not sufficient to prevent renal scarring in most children with UTI. Because signs of UTI in children are relatively non-specific, the diagnosis is often delayed. data from many studies have shown that once the infection has localized to the renal parenchyma, treatment with antibiotics alone does not prevent scarring. hence ,It is clear that the current management is not always effective in preventing renal scarring. The proposed study aims to determine whether dexamethasone therapy - which focuses on modulation of the host inflammatory response - is effective in reducing renal scarring.
115 studies on the registry are indexed under Glomerulonephritis; 32 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 87 interventional studies indexed under Glomerulonephritis.
Browse Glomerulonephritis studies →Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexamethasone
Drug: Dexamethasone Oral
Drug: Placebo
Drug: Placebo
Drug: Dexamethasone 0.3mg/kg/dose twice daily for 3 days
Also known as: corticosteroids
Placebo
Renal scarring comparatively with patients those don't take the medicine
Division of Children With Renal Scarring at the Outcome of (DMSA) Renal Scan \[ Time Frame: The outcome DMSA scan will be 6 months from enrollment.\] Renal scarring is defined as decreased uptake of tracer with or without loss of contours. Three radiologists independently will review all renal DMSA scans for scarring . Diagnosis of presence or absence of renal scarring for a kidney , should be endorsed by the majority of readers (2/3). The child will be determined to have renal scarring if either kidney or both kidneys have scarring by the majority of readers.
Time frame: 6 months
Plan to share: No
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Studies of the drug tested here: Dexamethasone