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 Vikash R. Keshri Moderator: Dr. P. R. Deshmukh

Learning Objective To learn Surveillance.

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.

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.

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.

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.

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.

Results: Total 3800 enrolled. 66 excluded from per protocol Analysis. Table 1: Number and Distribution of subjects with AGE. CountryED (N= 2057) Hospitalized (N= 1560) Nosocomial (N= 117) Total (N= 3734) n%n%n%n% France Germany Italy Spain United Kingdom Total

Table 2. Proportion of rotavirus gastroenteritis according to age group. nRVGE – No. of cases with rotavirus acute gastroenteritis. Age GroupEDHospitalizedTotal (n= 2928) nRV GE % RV Posi tive (C. I.) Age grou p % nRV GE % RV Posi tive (C. I.) Age grou p % nRV GE % RV Posi tive (C. I.) Age grou p % All subjects ( ) ( ) ( ) < 6 Months to <12 months to < to < 60 months

Table 3: Characteristics of Community Acquired Rotavirus Positive and Negative AGE Cases (Combined ED & Hospitalized) CharacteristicsRotavirus Positive (N= 1271), n (%) Rotavirus Negative (N=1657), n (%) Severity (Vesikari Scale)(n= 1183) Mild ( 1-6)165 (13.9)501 (31.5) Moderate (7- 10)387 (32.7)598 (37.5) Severe ( ≥ 11)631 (53.3)494 (31.0) Symptom Before ED visit or Hospitalization Vomiting1049 (82.5)957 (57.8) Fever726 (57.1)760 (45.9) Change in Behaviors907 (71.4)943 (56.9) Weight Loss444 (34.9)363 (21.9) Degree of Dehydration No Dehydration301 (23.7)745 (45.0) Mild or Moderate818 (64.4)825 (49.8) Severe143 (11.3)78 (4.7) Treatment Received Oral Rehydration601 ( 47.3)782 (47.2) I V Rehydration Therapy714 ( 56.2)522 ( 31.5)

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.

Discussion Cont…… Children < 2 years ( 80.9%) & < 6 months (15.9%) accounts for most cases of Community acquired RVGE. - Van Damme et al 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%

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.

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.

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