Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

NCT01171144 | Completed

• 1 other identifier: 111757
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children \< 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.

Conditions

Gastroenteritis

Outcome Measures

Primary Outcomes (3)

• Occurrence of all cause reported gastroenteritis

  In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

• Occurrence of all cause gastroenteritis related hospital discharges

  In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)

• Occurrence of all cause gastroenteritis related deaths.

  In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

Secondary Outcomes (3)

• Occurrence of all cause gastroenteritis-related cases by year, age groups and region

  From 1990 to 2010

• Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting

  From 2000 to 2010

• Occurrence of all cause gastroenteritis related deaths by year, age groups and region

  From 1990 to 2010

Study Arms (1)

Gastroenteritis Group

All children suffering with gastroenteritis

Other: Epidemiologic Surveillance System of the Ministry of Health of Panama; Other: Mortality database of the Contraloria General de la Republica; Other: Hospital discharge records

Interventions

Epidemiologic Surveillance System of the Ministry of Health of Panama OTHER

Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama

Gastroenteritis Group

Mortality database of the Contraloria General de la Republica OTHER

Reviewing the Mortality database of the Contraloria General de la Republica

Gastroenteritis Group

Hospital discharge records OTHER

Reviewing the hospital discharge records

Gastroenteritis Group

Eligibility Criteria

• Age: Up to 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All children \<5 years of age reported with gastroenteritis, gastroenteritis related hospital discharges and gastroenteritis related deaths in Panama, between 1990 and 2010.

You may qualify if:

• Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children \<5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, will be collected for the study.

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Panama City, Panama

Location

Biospecimen

Retention: NONE RETAINED

No samples are retained.

MeSH Terms

Conditions

Gastroenteritis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 28, 2010
• Study Start: January 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 7, 2017

Record last verified: 2017-06

Locations

PA (1)