Completed

Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media in Children Aged 6 Months to Less Than 30 Months in Panama

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Other
Who is being recruted

Bacterial Infections and Mycoses+6

+ Bacterial Infections

+ Ear Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Family-Based

Studying health outcomes within families in order to identify genetic or familial contributions to disease.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: December 7, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

The study is a cross sectional survey in which primary caregivers will be asked if they recall having observed an ear infection in the child in the age range 6 months to less than 30 months in the last 6 months. During the interview, the primary caregivers will be asked what they did for the child during that episode and whether they sought medical care or not. They will be also asked about the demographic characteristics (such as age range) of the child who experienced that episode and the household environment of the child at the time of the episode (such as number of household members), etc. No questions will be asked about the episode itself if the primary caregiver does not recall that the child had one in the last six months. Approximately 1300 primary caregivers will be interviewed in multiple clinics / well-baby clinics in Panama. The clinics will be stratified into 'former clinical trial sites' and 'non-clinical trial sites' in urban areas of Panama, based on participation in the COMPAS trial. Both 'former clinical trial sites' and 'non-clinical trial sites' will include private and public facilities. Sites will be selected by convenience sampling and eligible subjects will be enrolled on an on-going basis, in proportion to the population coverage of each site. The participating sites have thus been stratified to be able to assess whether the healthcare seeking behaviour of primary caregivers enrolled at former clinical trial sites are different from those enrolled at non clinical trial sites.

Principal SponsorGlaxoSmithKline
Last updated: December 7, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1330 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Family-Based

These studies involve members of the same family to explore how genetics and shared environments may contribute to a disease. They help researchers pinpoint inherited risk factors.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsEar DiseasesInfectionsOtorhinolaryngologic DiseasesGram-Positive Bacterial InfectionsOtitisOtitis MediaStreptococcal Infections

Criteria

Inclusion Criteria: Subjects who the investigator/interviewer believes can and will comply with the requirements of the protocol (e.g. availability of time for completion of the interview). Signed informed consent obtained from the subject. Subjects aged 18 years or above, being the primary caregiver of at least one child aged 6 months to less than 30 months, visiting a clinic. Note: i. Although the child will most likely be present at the time of interview, his/her presence is not required. ii. If more than one primary caregiver fulfilling the inclusion criteria is present per child, only one will be enrolled in this study. Exclusion Criteria: • Subjects having previously participated in this survey.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

GSK Investigational Site

La Chorrera, PanamaOpen GSK Investigational Site in Google Maps

GSK Investigational Site

Panama City, Panama

GSK Investigational Site

Arraiján, Panama

GSK Investigational Site

Barrio Colón, Panama
Completed13 Study Centers