Optimising Antibiotic Use for Paediatric Lower Respiratory Tract Infections in Africa

NCT07841691 | Recruiting DMC

• 1 other identifier: M250901
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Respiratory Tract Infection (LRTI); Pneumonia; Bronchopneumonia; Bronchiolitis

Keywords

Antimicrobial stewardship; Antibiotic prescribing; Lower respiratory tract infection; Antibiotic use; Pneumonia; Bronchiolitis; Bronchopneumonia; C-Reactive Protein; CRP; Point-of-care testing; PREPARE score; Clinical severity score; Risk stratification; Hospitalised children; Childhood pneumonia; Antimicrobial resistance; Clinician attitudes; Implementation science; South Africa

Outcome Measures

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.

  From randomisation (day of admission) until hospital discharge (up to 28 days post-randomisation)

Secondary Outcomes (7)

• Number of participants who die within 28 days of randomisation

  From randomisation through 28 days after randomisation

• Antibiotic treatment cost per participant

  From randomisation until discharge from the index hospitalisation, up to 28 days

• Number of participants readmitted to hospital within 28 days of randomisation

  From discharge from the index hospitalisation through 28 days after randomisation

• Number of Participants Experiencing at Least One Adverse Event Within 28 Days of Randomisation

  From randomisation through 28 days after randomisation

• Number of Participants Requiring Invasive Mechanical Ventilation

  From randomisation until discharge from the index hospitalisation, up to 28 days

Study Arms (2)

Intervention arm: CRP- and PREPARE-Guided Antibiotic Use

EXPERIMENTAL

Participants will receive antibiotic prescribing guidance based on serial point-of-care CRP measurements and repeated PREPARE clinical severity score assessments in addition to routine clinical care.

Diagnostic Test: CRP- and PREPARE-guided Antibiotic Prescription

Control: Standard of Care

NO INTERVENTION

Participants will receive routine clinical management according to existing hospital and unit-specific practice. Antibiotic prescribing decisions will be made by the treating clinical team without guidance from the study intervention, including point-of-care CRP testing and the PREPARE clinical severity score algorithm

Interventions

CRP- and PREPARE-guided Antibiotic Prescription DIAGNOSTIC_TEST

Antibiotic 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.

Intervention arm: CRP- and PREPARE-Guided Antibiotic Use

Eligibility Criteria

• Age: 2 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 2-24 months
• Clinician diagnosis of lower respiratory tract infection (LRTI)

You may not qualify if:

• Transferred from other hospitals with more than 24 hours of hospitalisation
• Hospitalisation within the preceding 30 days

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Chris Hani Baragwanath Academic Hospital

Johannesburg, Gauteng, 2198, South Africa

RECRUITING

MeSH Terms

Conditions

Pneumonia; Bronchopneumonia; Bronchiolitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Bronchitis; Lung Diseases, Obstructive

Study Officials

• Lucy N Wilson, MBBCh, MMED, FCPaed

  University of Witwatersrand, South Africa

  PRINCIPAL INVESTIGATOR

• David P Moore, PhD

  University of Witwatersrand, South Africa

  STUDY DIRECTOR

• Chris A Rees, PhD

  Emory University

  STUDY CHAIR

• Ziyaad Dangor, PhD

  University of the Witwatersrand Vaccines and Infectious Diseases Analytics (Wits VIDA) Research Unit

  STUDY CHAIR

Central Study Contacts

Lucy N Wilson, MBBCH, MMED, FCPaed

CONTACT

+27 72 326 7888; lucy.wilson@wits-vida.org

Ziyaad Dangor, MBBCh

CONTACT

+27 83 471 0933; ziyaad.dangor@wits-vida.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study with no masking. Participants will be randomized to either an intervention arm, in which antibiotic prescribing is guided by serial point-of-care CRP measurements and PREPARE clinical severity score assessments, or a routine care control arm. Treating clinicians and study personnel will be aware of treatment allocation because implementation of the intervention requires access to CRP results and severity scores to guide antibiotic use.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Paediatrician

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an intervention group or a routine care control group. Children in the intervention group will receive antibiotic prescribing guidance based on serial point-of-care C-reactive protein (CRP) measurements and repeated PREPARE clinical severity score assessments in addition to routine clinical evaluation. Children in the control group will receive standard clinical care according to existing hospital practice and national treatment guidelines. Antibiotic use, outcomes and healthcare related costs will be compared between the two parallel study arms.

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 25, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)