GastroenteritisNCT01171144
Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama
An observational study of Gastroenteritis, run by GlaxoSmithKline at 1 site in Panama.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 59 months
- Conditions the study is for
- Gastroenteritis
- What is being tested?
- Epidemiologic Surveillance System of the Ministry of Health of Panama, Mortality database of the Contraloria General de la Republica and Hospital discharge records
- How many people
- 1 participants
- Where
- 1 sitePanama
- Study dates
- Jan 2009to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 59 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010
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.
Read the detailed description
Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.
- Conditions
- Gastroenteritis
- Being tested
- Epidemiologic Surveillance System of the Ministry of Health of Panama, Mortality database of the Contraloria General de la Republica, Hospital discharge records
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidemiologic Surveillance System of the Ministry of Health of PanamaOther
Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama
Mortality database of the Contraloria General de la RepublicaOther
Reviewing the Mortality database of the Contraloria General de la Republica
Hospital discharge recordsOther
Reviewing the hospital discharge records
| Study group | Role | What they receive |
|---|---|---|
| Gastroenteritis Group | All children suffering with gastroenteritis Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of all cause reported gastroenteritis
Measured: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Occurrence of all cause gastroenteritis related hospital discharges
Measured: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Occurrence of all cause gastroenteritis related deaths.
Measured: 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
Measured: From 1990 to 2010
Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting
Measured: From 2000 to 2010
Occurrence of all cause gastroenteritis related deaths by year, age groups and region
Measured: From 1990 to 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJan 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171144
- Sponsor's protocol ID
- 111757
- Status last verified
- Jun 2017
- First submitted
- 15 Jul 2010
- Last updated
- 7 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010
- ClinicalTrials.gov ID
- NCT01171144
- Acronym / sponsor ID
- 111757
- Conditions
- Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroenteritis Group | – | Other: Epidemiologic Surveillance System of the Ministry of Health of Panama, Other: Mortality database of the Contraloria General de la Republica, Other: Hospital discharge recordsAll children suffering with gastroenteritis |
Who may qualify
- Ages
- Up to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidemiologic Surveillance System of the Ministry of Health of PanamaReviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama | Other | Gastroenteritis Group |
| Mortality database of the Contraloria General de la RepublicaReviewing the Mortality database of the Contraloria General de la Republica | Other | Gastroenteritis Group |
| Hospital discharge recordsReviewing the hospital discharge records | Other | Gastroenteritis Group |
Primary outcome
Occurrence of all cause reported gastroenteritis
Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Occurrence of all cause gastroenteritis related hospital discharges
Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Occurrence of all cause gastroenteritis related deaths.
Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
3 secondary outcomes
Occurrence of all cause gastroenteritis-related cases by year, age groups and region
Time frame: From 1990 to 2010
Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting
Time frame: From 2000 to 2010
Occurrence of all cause gastroenteritis related deaths by year, age groups and region
Time frame: From 1990 to 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis, run by GlaxoSmithKline at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of all cause reported gastroenteritis (time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2017.