Rotavirus Infections Clinical Trial
Official title:
Multicenter Study for Surveillance of Hospitalizations Due to Rotavirus-Associated Diarrhea and Estimation of the Economic Burden of Rotavirus Hospitalizations
Objectives
1. To determine the burden and characteristics of rotavirus-associated hospitalizations
among children under five years of age of northern Israel
2. To identify potential risk factors of rotavirus infections associated with
hospitalizations among Jewish and Arab children younger than five years of age.
Methods:
Study design: A two-year prospective study and a nested case control study will be carried
out Collection of data: Questionnaires will be filled in with demographic characteristics of
patients and data on the clinical manifestation of the diarrheal episode leading to
hospitalization. Stool specimens will be systematically collected from all children
hospitalized because of diarrheal diseases and examined for rotavirus and for bacterial and
protozoan enteropathogens. Positive samples for rotavirus will be tested for G and P
genotypes.
For the nested case control study additional data will be obtained from parents' interviews
on variables such as: parents' education, parents' age, parents' occupation, no. of
siblings, age of siblings, breastfeeding etc. to identify potential risk factors for
rotavirus diarrhea necessitating hospitalization.
Data analysis: Methods of descriptive statistics / epidemiology will be applied to determine
the characteristics of the burden of rotavirus-associated hospitalizations (the distribution
of diarrhea associated hospitalizations by etiology, rates of rotavirus diarrheal diseases
in Jewish and Arab children, age specific rates of rotavirus infections, the percentage of
hospitalizations due to rotavirus diarrhea by month, etc.
For the nested case control study, univariate analysis will be first performed using Student
t test for continuous variables and chi square test for categorical variables to study the
statistical significance of predictive factors of rotavirus diarrheal diseases necessitating
hospitalization. Multivariate analysis using logistic regression models will be performed to
study the independent effect of each variable. Odds ratios (OR) and 95% CI will be computed
for each variable. Two tailed p < 0.05 will be considered significant.
Status | Not yet recruiting |
Enrollment | 2500 |
Est. completion date | September 2009 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 1 Month to 5 Years |
Eligibility |
Inclusion Criteria: - Age: under five year old - Hospitalization due diarrheal disease within the study period in the pediatric wards participating in the study - Controls: hospitalization due non-gastrointestinal causes within the study period in the pediatric wards participating in the study Exclusion Criteria: - Refusal |
Observational Model: Defined Population, Time Perspective: Longitudinal
Country | Name | City | State |
---|---|---|---|
Israel | Carmenl Medical Center | Haifa | |
Israel | Laniado Medical Center | Netanya |
Lead Sponsor | Collaborator |
---|---|
Hillel Yaffe Medical Center | Carmel Medical Center, Laniado Medical Center Netanya, Ministry of Health, Israel, Tel Aviv University, The Meshulash Research and Development Center Kfar Qaraa |
Israel,
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02538211 -
The Role of the Intestinal Microbiome in Enteric and Systemic Vaccine Immune Responses
|
N/A | |
Completed |
NCT02220439 -
Does the Fecal Microbiome Influence Rotarix Immunogenicity
|
N/A | |
Withdrawn |
NCT00757926 -
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
|
Phase 1/Phase 2 | |
Completed |
NCT00092443 -
Dose Confirmation Efficacy Study (V260-007)
|
Phase 3 | |
Terminated |
NCT01357174 -
ROTATEQ™ Post-Marketing Surveillance in the Philippines
|
N/A | |
Recruiting |
NCT01363726 -
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
|
N/A | |
Completed |
NCT00130832 -
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
|
Phase 3 | |
Recruiting |
NCT06080906 -
Phase II Clinical Trial of the Inactivated Rotavirus Vaccine
|
Phase 2 | |
Recruiting |
NCT03313128 -
SaniVac Trial - Sanitation and Oral Rotavirus Vaccine Performance
|
||
Completed |
NCT02542462 -
Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study
|
Phase 4 | |
Completed |
NCT00346892 -
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
|
Phase 2 | |
Not yet recruiting |
NCT05212935 -
A Surveillance Study on Timing and Coverage Of Rotavirus and MenB Vaccine Co-administration in Campania Region, Italy
|
||
Completed |
NCT00092456 -
Consistency Lots Vaccine Study (V260-009)
|
Phase 3 | |
Completed |
NCT00981669 -
Rotavirus Vaccine Produced by Butantan Institute
|
Phase 1 | |
Completed |
NCT05037435 -
Safety and Immunological Efficacy of the Pentavalent Rotavirus Vaccine - Rota-V-Aid™ (Live Attenuated Oral, Freeze-dried) at Healthy Adults Aged 18 to 45 Years.
|
Phase 3 | |
Completed |
NCT03483116 -
A Phase II Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine
|
Phase 2 | |
Completed |
NCT03870061 -
Evaluation of an Infant Immunization Encouragement Program in Nigeria
|
N/A | |
Active, not recruiting |
NCT05621655 -
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
|
Phase 2 | |
Completed |
NCT00280111 -
Safety and Immunogenicity Study of Live Attenuated Indian Rotavirus Vaccine Candidate Strains 116E and I321 in Infants
|
Phase 1 | |
Completed |
NCT00090233 -
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
|
Phase 3 |