Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania

Browse trials for

• Rotavirus Infections 101
• Gastroenteritis 243

Keywords

• Gastroenteritis
• Hospital surveillance
• Rotavirus gastroenteritis

Rotavirus Infections

101 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 1,234 is above the median of 885 across 31 observational studies indexed under Rotavirus Infections.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Study population

Groups and cohorts

• Group A

  Subjects who are hospitalised for acute gastroenteritis

  Procedure: Collection of stool samples · Other: Health economics questionnaire

• Group B

  Subjects who visit an emergency room for acute gastroenteritis

  Procedure: Collection of stool samples · Other: Health economics questionnaire

• Group C

  Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

  Procedure: Collection of stool samples · Other: Health economics questionnaire

Interventions

• ProcedureCollection of stool samples

  Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.

• OtherHealth economics questionnaire

  For a subset of subjects, additional economic data will be gathered by completing a questionnaire

Primary outcomes

1. Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age

   Time frame: At least 12 months from study start

2. Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age

   Time frame: At least 12 months from study start

3. Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age

   Time frame: At least 12 months from study start

Secondary outcomes

1. Age distribution of children with rotavirus gastroenteritis

   Time frame: At least 12 months from study start

2. Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age

   Time frame: At least 12 months from study start

3. Potential risk factors for rotavirus gastroenteritis

   Time frame: At least 12 months from study start

4. Rotavirus gastroenteritis associated costs

   Time frame: At least 12 months from study start

5. Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age

   Time frame: At least 12 months from study start

6. Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age

   Time frame: At least 12 months from study start

7. Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age

   Time frame: At least 12 months from study start

8. Severity of rotavirus among all children < 5 years of age

   Time frame: At least 12 months from study

9. Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age

   Time frame: At least 12 months from study start

10. Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age

    Time frame: At least 12 months from study start

Publications

• Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep. PubMed 25276665 ↗
• Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun. PubMed 24967217 ↗