Condition category
Infections and Infestations
Date applied
09/12/2019
Date assigned
11/12/2019
Last edited
09/04/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

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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

01/06/2020

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

https://www.undip.ac.id/language/id/

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

Publication citations

Additional files

Editorial Notes

09/04/2020: The recruitment start date was changed from 01/03/2020 to 01/06/2020. 11/12/2019: Trial's existence confirmed by Diponegoro University Faculty of Medicine Health Research Ethics Committee.