Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-24
SponsorUniversity of Witwatersrand, South Africa
About this trial
Lower respiratory tract infections (LRTIs) remain a leading cause of hospitalisation and death among young children in Africa. Although viral infections account for a substantial proportion of LRTIs, antibiotics are frequently prescribed because distinguishing between viral and bacterial infections can be challenging. This contributes to unnecessary antibiotic exposure and the rising global public health challenge of antimicrobial resistance.
This pragmatic, unblinded randomised controlled study will evaluate whether the combination of point-of-care (POC) C-reactive protein (CRP) testing and the PREPARE clinical severity score can safely reduce antibiotic use among children aged 2 to 24 months hospitalised with LRTI at Chris Hani Baragwanath Academic Hospital (CHBAH), South Africa. Participants will be randomly assigned in a 1:1 ratio to either the intervention group, where antibiotic decisions are guided by serial POC CRP measurements and repeated PREPARE severity assessments, or a control group receiving routine clinical care.
The primary objective of the study is to compare antibiotic use during hospitalisation between the intervention and control groups. Secondary objectives are to evaluate the safety of this approach by comparing mortality, hospital readmission within 28 days, adverse events, need for invasive ventilation, duration of hospitalisation, and other clinical outcomes between study groups. In addition, the study will compare healthcare-related costs, including antibiotic expenditure and costs associated with hospitalisation.
A parallel mixed-methods component will explore clinician attitudes, beliefs, and determinants of antibiotic prescribing for children hospitalised with LRTI using surveys, focus groups discussions, and individual interviews informed by the Theoretical Domains Framework (TDF). Findings will help identify behavioural and system-level factors that influence antibiotic prescribing and inform future antimicrobial stewardship interventions.
This study aims to generate evidence on whether biomarker-guided and risk-stratified care can safely optimise antibiotic use among young African children hospitalised with LRTI while improving antimicrobial stewardship and reducing healthcare costs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children between the ages of 2-24 months
Clinician diagnosis of lower respiratory tract infection (LRTI)
Disqualifiers
Transferred from other hospitals with more than 24 hours of hospitalisation
Hospitalisation within the preceding 30 days
Trial design
Design model
Parallel
Treatments tested in this trial
CRP- and PREPARE-guided Antibiotic Prescription
Diagnostic testAntibiotic prescribing is guided by serial point-of-care CRP measurements and repeated PREPARE clinical severity score assessments. A predefined algorithm incorporating CRP results and clinical severity assessment is used to support decisions regarding antibiotic initiation, continuation, and discontinuation in children hospitalised with lower respiratory tract infections.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Intervention arm: CRP- and PREPARE-Guided Antibiotic UseExperimental treatment 1 intervention
Group B: Control: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Antibiotic use during hospitalisation
Antibiotic use among children hospitalised with lower respiratory tract infection, including antibiotic initiation, route of administration, duration of therapy, and early discontinuation of antibiotics during the index hospital admission.
Time frame
From randomisation (day of admission) until hospital discharge (up to 28 days post-randomisation)Secondary outcomes
1
Number of participants who die within 28 days of randomisation
Number of participants who die from any cause within 28 days after randomisation. This outcome will be compared between the intervention and routine care groups.
Time frame
From randomisation through 28 days after randomisation2
Antibiotic treatment cost per participant
Total cost of systemic antibiotic treatment received by each participant from randomisation until discharge (up to 28 days following randomisation) from the index hospitalisation. Antibiotic costs will be calculated using the antibiotics administered, duration of treatment, and applicable unit costs. Mean or median cost per participant will be compared between the intervention and routine care groups and reported in South African rand.
Time frame
From randomisation until discharge from the index hospitalisation, up to 28 days3
Number of participants readmitted to hospital within 28 days of randomisation
Number of participants who are readmitted to hospital for any cause following discharge from the index admission and within 28 days after randomisation. This outcome will be compared between the intervention and routine care groups.
Time frame
From discharge from the index hospitalisation through 28 days after randomisation4
Number of Participants Experiencing at Least One Adverse Event Within 28 Days of Randomisation
Number of participants who experience at least one adverse event within 28 days after randomisation, according to the adverse event definition specified in the study protocol. Participants experiencing more than one adverse event will be counted once for this participant-level outcome
Time frame
From randomisation through 28 days after randomisationSponsors and contacts
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Source ClinicalTrials.gov