There is one clinical trial.
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses. Most physicians in India use the standard Augmentin (amoxicillin:clavulanic acid 7:1) (45/6.4 mg/kg/day) formulation and double the dose to achieve higher dose of amoxicillin/clavulanic acid at 90 mg/kg/day in pediatric acute otitis media (AOM) due to non-availability of Augmentin (ES)-600. Using the 7:1 formulation causes unnecessary exposure to higher proportionate dose of clavulanic acid (12.8 mg/kg/day) as a unit dose of 6.4 mg/kg/day of clavulanic acid is only required for efficacy against beta-lactamase producing AOM pathogens. Hence, there is an unmet need for availability of Augmentin (ES)-600 in India. This is an open label, single arm, multicenter, non-comparative study in participants aged 6 months to 12 years with AOM. It aims to assess the safety and clinical efficacy of Augmentin (ES)-600 administered in two divided doses, every 12 hours in pediatric population in India. AUGMENTIN is a registered trademark of the GlaxoSmithKline group of companies.
Description: TEAEs and SAEs will be collected.Measure: Number of participants with treatment emergent adverse events (TEAE) and serious adverse events (SAEs) Time: From start of treatment (Day 1) to follow-up visit at Day 28
Description: Primary clinical response will be assessed at the end of therapy (EOT) visit (Day 12 to 14) in terms of success or failure to study intervention. A treatment success at EOT will be defined as either clinical cure or improvement. A treatment failure will be defined as a participant whose clinical outcome will be clinical failure (due to worsening or non-improvement in symptoms) or "unable to determine".Measure: Number of participants achieving Primary Clinical Response Time: From start of treatment (Day 1) to end of therapy visit at Day 12-14
Description: Secondary clinical response will be assessed at follow-up (Day 22 to 28) in terms of success or failure to study intervention. A treatment success at follow-up will be defined as persistent clinical cure and treatment failure will be clinical recurrence or unable to determine.Measure: Number of participants achieving Secondary Clinical response Time: From end of treatment visit (Day 12-14) to follow up visit at Day 22-28
Description: Protocol-defined diarrhea is 3 or more watery stools in one day or 4 or more loose/watery stools in one day or 2 watery stools per day for two consecutive days or 3 loose/watery stools per day for two consecutive days.Measure: Number of participants with protocol defined diarrhea (PDD) (due to study medication) Time: From start of treatment (Day 1) to end of therapy visit at Day 12-14
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports