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Johannes Foster, Alfredo Guarino, et al. Pediatrics, March 2009, Vol. 123 (3), p 393-400

Hospital Based Surveillance to Estimate the Burden of Rotavirus Gastroenteritis Among European Children Younger than 5 Years of Age. Johannes Foster, Alfredo Guarino, et al. Pediatrics, March 2009, Vol. 123 (3), p 393-400. Vikash R. Keshri Moderator: Dr. P. R. Deshmukh.

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Johannes Foster, Alfredo Guarino, et al. Pediatrics, March 2009, Vol. 123 (3), p 393-400

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  1. Hospital Based Surveillance to Estimate the Burden of Rotavirus Gastroenteritis Among European Children Younger than 5 Years of Age Johannes Foster, Alfredo Guarino, et al. Pediatrics, March 2009, Vol. 123 (3), p 393-400 Vikash R. Keshri Moderator: Dr. P. R. Deshmukh

  2. Learning Objective • To learn Surveillance.

  3. Introduction • Rotavirus leading cause of Acute Gastroenteritis (AGE) among infants and children. • WHO strongly recommends vaccine if public health impact is significant. • Two vaccines are licensed: Rotarix: A live attenuated G1P Human rotavirus vaccine. Rota teq: live human bovine reassorant vaccine. • Data needed to estimate burden of disease. • Current data based mostly on retrospective assessment: can underestimate the burden. • SHRIK (Surveillance for Hospitalized Rotavirus Infection in Kids) : A Prospective, Multicentre Hospital based study.

  4. Study Objectives: • To estimate the proportion of rotavirus gastroenteritis among all hospitalized and emergency department visits because of community Acquired AGE in children less than 5 Years of Age. • The incidence of Nosocomial rotavirus AGE among all hospitalized children less than 5 years of age.

  5. Methodology • Study Design: Prospective Study. • Study Area: 12 Hospitals in France, Germany, Italy, Spain and United kingdom. • Study Population: Inclusion Criteria: - children < 5 years of age at the time of admission and hospitalized or accessed an ED due to Community Acquire AGE. - Children < 5 years developed AGE within 48 hours of hospitalization with rotavirus positive laboratory result.

  6. Exclusion criteria : Only Consent not given. Case Definition: AGE: Diarrhea ( ≥ 3 loose stools within 24 hours ) for < 14 days at enrolment. • Sampling Strategy: Staggered enrolment every 2 weeks. Target Enrolment: Based on burden of disease and seasonality for every 2 weeks. • Study Duration: 12 months period between Feb 2005 to Aug.2006.

  7. Data collection: - Informed consent. - Routine medical Examination by Paediatrician. - Interview with parents/Guardian. - Review of medical files after discharge. - Telephonic follow up after 15 days for Disease Outcome. Stool Sample: - within 10 days of AGE symptom. - Refrigerated and frozen sample sent to laboratory. - ELISA and RT PCR test done to Specify the G & P types. Data Analysis: - Data Summarized in frequency tables and statistical analysis done using SAS 8.2 software.

  8. Results: • Total 3800 enrolled. 66 excluded from per protocol Analysis. Table 1: Number and Distribution of subjects with AGE.

  9. Table 2. Proportion of rotavirus gastroenteritis according to age group. nRVGE – No. of cases with rotavirus acute gastroenteritis.

  10. Table 3: Characteristics of Community Acquired Rotavirus Positive and Negative AGE Cases (Combined ED & Hospitalized)

  11. Discussion: • SHRIK most recent study to access Rotavirus disease burden among European Children. • Results confirm rotavirus as major cause of AGE among Children < 5 Years of age (43.4%). • Among all cause admission in ED or Hospitalization - RVGE ranges from 0.93 to 3.84% & 0.25 to 8.23%. • Above Finding consistent with similar findings: - Van Damme, et al. - PROTECT study. - Soriano Gabbarano et al. • Findings may be same in countries with similar demographic characteristics as in USA. Malek MA, et al.

  12. Discussion Cont…… • Children < 2 years ( 80.9%) & < 6 months (15.9%) accounts for most cases of Community acquired RVGE. - Van Damme et al. 56.7 to 74.2% among 6 to 23 month and 18.1 to 31.9% in age < 6 months. • Severity of RVGE is more (table 3). • Rotavirus types most prevalent G1P[8] & G9P[8]. Differed from previous rotavirus study ( Van Damme et al. REVEAL study). • Seasonal and geographic variability seen in rotavirus types. • Proportion of Nosocomial RVGE among < 2 years and < 6 months respectively is 95.7% & 42.7%

  13. Strength & limitations of study Strength: • Well Established case definitions & standard data collection. • Laboratory confirmation: single reference lab. • Large study population ( N = 3734). Limitations: • Variation in clinical practice and M/M of AGE cases. • Information on total < 5 child not available in all countries. • Target enrollment not ideal representation. • Hospital setting: more severe cases, higher probability of RVGE.

  14. Conclusions: • Rota virus gastroenteritis places high demand on European health care system. • Vaccine can be given high priority. • Vaccine can have major impact in reducing the burden of disease and hospital load due to AGE. • Needs for vaccine to provide protection for first 2 years of life and possibly among < 6 months of age.

  15. Your comments??????

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