FLAT-CAP Trial

Optimising First-Line Amoxicillin for Non-Severe Childhood Pneumonia in Africa: A Pragmatic Non-Inferiority Trial of Simplified Dosing, Shortened Treatment Duration, and Follow-Up (FLAT-CAP Trial)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

PACTR

Registry ID

PACTR202606562465472

Enrollment

8000

Registered

2026-06-04

Start date

2026-10-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Paediatrics

Interventions

Oral Amoxicillin

Duration optimisation

Followup optimisation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: children aged 2–59 months with non-severe community-acquired pneumonia, defined by protocol-specified WHO-aligned criteria: fast breathing and/or chest indrawing without danger signs, suitable for outpa-tient oral amoxicillin, and with a caregiver able to provide informed consent and comply with follow-up

Exclusion criteria

Exclusion criteria: severe disease or danger signs requiring admission or referral, hypoxaemia below the protocol threshold, in-ability to tolerate oral medication, known amoxicillin allergy or contraindication, recent trial enrolment, or any major comorbidity making outpatient participation unsafe

Design outcomes

Primary

Measure	Time frame
Outcome 1: Policy-ready evidence on the minimum effective outpatient amoxicillin package. We will generate definitive multicountry evidence on whether simplified dosing, shortened treatment duration, and lighter but safe follow-up preserve acceptable early clinical outcomes in African children with non-severe community-acquired pneumonia. This will support guideline revision, programme adaptation, and WHO-facing technical dialogue on practical outpatient treatment packages for African service-delivery settings. ;Outcome 2: A stewardship-informed framework for childhood pneumonia treatment. Unlike older trials focused mainly on clinical cure or treatment failure, FLAT-CAP will also examine ecologi-cal and stewardship consequences. By comparing total antibiotic exposure and embedding nested studies on antimicrobial-resistance carriage, resistome effects, and microbiome disruption, the project will link clinical ef-fectiveness with ecological consequence. ;Outcome 3: A scalable implementation model for real-world African health systems. We will generate evidence on adherence, tolerability, caregiver administration, fidelity, CHW workload, acceptability, household cost, and health-system cost-effectiveness. This will help ministries and child-health programmes judge not only what is clinically acceptable, but also what is feasible, affordable, and scalable across African outpatient settings.	—

Measure

Time frame

Outcome 1: Policy-ready evidence on the minimum effective outpatient amoxicillin package. We will generate definitive multicountry evidence on whether simplified dosing, shortened treatment duration, and lighter but safe follow-up preserve acceptable early clinical outcomes in African children with non-severe community-acquired pneumonia. This will support guideline revision, programme adaptation, and WHO-facing technical dialogue on practical outpatient treatment packages for African service-delivery settings. ;Outcome 2: A stewardship-informed framework for childhood pneumonia treatment. Unlike older trials focused mainly on clinical cure or treatment failure, FLAT-CAP will also examine ecologi-cal and stewardship consequences. By comparing total antibiotic exposure and embedding nested studies on antimicrobial-resistance carriage, resistome effects, and microbiome disruption, the project will link clinical ef-fectiveness with ecological consequence. ;Outcome 3: A scalable implementation model for real-world African health systems. We will generate evidence on adherence, tolerability, caregiver administration, fidelity, CHW workload, acceptability, household cost, and health-system cost-effectiveness. This will help ministries and child-health programmes judge not only what is clinically acceptable, but also what is feasible, affordable, and scalable across African outpatient settings.

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Secondary

Measure	Time frame
Secondary outcomes will include Day 14 failure, relapse, recurrence, hospitalisation, adverse events, adherence, non-study antibiotic use, total antibiotic exposure, and nested AMR and implementation outcomes.	—

Countries

Uganda

Contacts

Public ContactMary Ann Nagudi

Executive Personnal Assistant

marianne70@ymail.com+256779110755

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026