AI-enabled digital stethoscope to guide antibiotic use in young children with pneumonia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 trial in rural Bangladesh evaluates whether an AI-enabled digital stethoscope can help clinicians decide when antibiotics are needed for children with non-severe pneumonia, potentially reducing unnecessary antibiotic use. Children aged 2 to 59 months with symptoms up to 14 days and meeting IMCI non-severe pneumonia criteria are enrolled, have lung sounds recorded, and are randomized to an AI-guided antibiotic plan or standard care. In the intervention arm, lung-sound analysis determines antibiotic treatment, while all control participants receive standard antibiotic therapy per IMCI guidelines. The primary aim is to determine non-inferiority in treatment failure between the AI-guided approach and standard care. The study uses encrypted data transfer, randomized allocation after recording, and a 5-day antibiotic course when indicated by IMCI guidance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 2 to 59 months of age (60 days to 59 months 29 days),
* illness duration 14 days or less,
* meeting non-severe pneumonia criteria, and
* from the trial catchment areas.

Exclusion Criteria:

* prior participation,
* age \<2 months or \>59 months,
* illness duration \>14 days,
* not meeting IMCI-defined non-severe pneumonia criteria,
* oxygen saturation (SpO2) \<90%,
* moderate or severe malnutrition,
* known chronic disease,
* history of prematurity,
* one or more high risk clinical signs (any WHO-defined clinical danger sign and/or WHO-defined emergency sign),
* known antibiotic exposure in the past 1 week,
* non-respiratory illness requiring systemic antibiotic treatment according to IMCI guidelines.

Where it's running

• Projahnnmo Research Foundation
  Sylhet, Bangladesh Recruiting

Study contacts

• Principal investigator: Eric McCollum, MD, MPH — Johns Hopkins University
• Study coordinator: Eric D McCollum, MD, MPH
• Email: emccoll3@jhmi.edu
• Phone: 410-955-2035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.