Plain English Summary
Background and study aims
Even though identification and treatment has improved, pneumonia (inflammation and swelling of the lungs often caused by an infection) is the leading cause of death in children worldwide, with approximately 1 million deaths each year. Indonesia has a high rate of pneumonia in children, with 1 in 5 children aged under 5 years suffering from pneumonia each year. This study aims to observe children aged under 5 years in Indonesia who have pneumonia to investigate the type of infection that has caused it, the antibiotics that can kill the bacteria involved and the risk factors that make a child more likely to have pneumonia. The results are expected to help with planning treatment and vaccine use.
Who can participate?
Children aged under 5 years who have a cough or difficulty breathing and have fast breathing, as long as the first sign of illness was less than 14 days previously.
What does the study involve?
Children suspected of having pneumonia will be identified at community health centres in different parts of Indonesia. They will have blood samples taken as part of the study and will have their throat and nose swabbed so that bacteria and viruses can be identified. The parents will be asked questions to identify potential risk factors using a questionnaire.
What are the possible benefits and risks of participating?
This is an observational study, which means that the participants receive treatment as usual. There is no risk or benefit of participating.
Where is the study run from?
Diponegoro University (Indonesia)
When is the study starting and how long is it expected to run for?
October 2019 to October 2023
Who is funding the study?
Diponegoro University (Indonesia)
Who is the main contact?
Dr Vincentia Rizke Ciptaningtyas, ciptaningtyas_vr@fk.undip.ac.id
Trial website
Contact information
Type
Scientific
Primary contact
Mrs Vincentia Rizke Ciptaningtyas
ORCID ID
http://orcid.org/0000-0001-5910-4937
Contact details
Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
+62 81325755503
ciptaningtyas_vr@fk.undip.ac.id
Type
Public
Additional contact
Mrs Vincentia Rizke Ciptaningtyas
ORCID ID
http://orcid.org/0000-0001-5910-4937
Contact details
Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
+62 81325755503
Rizke.Ciptaningtyas@radboudumc.nl
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
RIDA261119
Study information
Scientific title
Investigation of the modifiable risk factors and etiology of lower respiratory tract infections of children under five years of age in Indonesia
Acronym
RIDA
Study hypothesis
A better understanding of the etiology, risk factors and antimicrobial resistance patterns among children with lower respiratory tract infection (LRTI) will improve the healthcare for these patients in Indonesia. Hence, reducing childhood morbidity and mortality caused by LRTI and thereby supporting the third ‘sustainable development goal’.
Ethics approval
Approved 04/12/2019, Diponegoro University Faculty of Medicine Health Research Ethics Committee (Kantor Dekanat Lama FK Undip lt.1, Jl. Dr. Soetomo 18, Semarang, Indonesia; +62 024-769280010 ext 7820; komisietik@gmail.com), ref: 506/EC/KEPK/FK UNDIP/XII/2019
Study design
Multicentre observational (longitudinal case-control) study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Community
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a participant information sheet.
Condition
Lower respiratory tract infection among children aged under 5 years
Intervention
This study is designed as a case control study, whereby cases will be matched with controls (matched by age, sex, time of admission ). Cases will be identified at community health center (Puskesmas) and controls will be enrolled by post for integrated services (Posyandu) where the community health center is located.
All participants will receive a one-time intervention immediately after they have given their consent. The researchers will take a medical history from the parent or carer and physically examine the children, including pulse oximetry. Nasopharyngeal swab, oropharyngeal swab and peripheral vein (blood and serum) will be taken. Information about risk factors will be obtained through a questionnaire designed specifically for this study. Questions in our questionnaire relate to caregiver socio-demographic information (specifically level of education and salary), participant socio-demographic information (specifically antenatal care, breastfeeding and previous illness), immunization status, home-related factors and tobacco exposure.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Etiology (with a primary focus on bacteria and viruses) of LRTI identified using conventional (bacterial culture) and molecular methods.
Secondary outcome measures
1. Risk factors assessed using parents' and guardians' responses to a questionnaire
2. Antimicrobial sensitivity patterns of isolated bacterial pathogens
3. Virus identification using multiplex PCR
4. Pneumococcal serotypes causing pneumonia identified using multiplex PCR and the Quellung reaction
Overall trial start date
01/10/2019
Overall trial end date
01/10/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cough or difficulty in breathing
2. Fast breathing:
2.1. In children aged 2 to 11 months, with breathing rate ≥50 breaths per min
2.2. In children aged 12 to 59 months, with breathing rate ≥40 breaths per min
3. First symptom appearing within the last 14 days
4. Aged under 5 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
450
Participant exclusion criteria
1. Hospitalized for more than 24 h at enrolment
2. Cancer or history of cancer
3. History of long-term (more than 2 months) exposure to steroid drugs
Recruitment start date
01/03/2020
Recruitment end date
01/10/2022
Locations
Countries of recruitment
Indonesia
Trial participating centre
Universitas Diponegoro
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
Sponsor information
Organisation
Universitas Diponegoro [Diponegoro University]
Sponsor details
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia
+62 24 76928010
dean@fk.undip.ac.id
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universitas Diponegoro
Alternative name(s)
Diponegoro University, UNDIP
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Indonesia
Results and Publications
Publication and dissemination plan
The findings from this research study will be published in an appropriate scientific journal (and made available open access) and/or presented at an appropriate meeting.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/10/2023
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list