| Eligibility |
Inclusion Criteria:
- History of cough <14 days or difficult breathing with fast breathing (for children 2
to <12 months of age, >50 breaths/minute and for children >12 months of age, > 40
breaths/minute).
- Ability and willingness of children's caregiver to provide informed consent and to be
available for follow-up for the planned duration of the study, including accepting a
home visit if he/she fails to return to Kamuzu Central Hospital (KCH) with the child
for a scheduled study follow-up visit.
Exclusion Criteria:
- If fast breathing observed at screening resolves after bronchodilator challenge.
- Chest-indrawing.
- Severe respiratory distress, classified by World Health Organization (WHO) pocketbook
guidelines (e.g., grunting, nasal flaring, head nodding, crackles on auscultation, or
very severe chest-indrawing).
- Presence of WHO Intergrated Management of Childhood Illness (IMCI) danger signs
including: lethargy or unconsciousness, convulsions, vomiting everything, or inability
to drink or breastfeed.
- Hypoxia (SaO2 < 90% on room air, as assessed by a Lifebox pulse oximeter).
- Stridor when calm.
- HIV-1 seropositivity or HIV-1 exposure, assessed as follows:
- An HIV-positive result upon rapid antibody test will exclude any child from this
study. If a child is less than 12 months or age or breastfeeding with a positive
rapid test result, the child will be referred to receive additional confirmatory
HIV testing (e.g., dried blood spot filter paper test) and follow-up from KCH
staff, as per standard of care. Even if the confirmatory HIV testing subsequently
shows that child is HIV-negative, he or she will remain excluded from the study.
- If a child is less than 12 months of age or breastfeeding and has an HIV-negative
result upon rapid antibody test, the child's biological mother's HIV status will
need to be assessed. If the mother is HIV-positive, the child will be excluded.
If the mother has a documented HIV-negative test result from within the past 3
months, the child will be included. If the mother does not have documentation of
an HIV-negative test result, she will be tested via rapid antibody testing to
determine the child's eligibility for this study.
- If a child is over 12 months of age and not breastfeeding, an HIV-negative rapid
antibody test is required for inclusion in the study.
- Note: If a child has documentation of an HIV-negative test result from within the
past 3 months, that test result will be used for the child's eligibility
assessment.
- Severe acute malnutrition (weight for height/length < -3 SD, mid-upper arm
circumference <115 mm, or edema).
- Possible tuberculosis (coughing for more than 14 days).
- Severe anemia, classified by WHO pocketbook guidelines (i.e., severe palmar pallor or
hemoglobin <8.0 g/dL).
- Severe malaria, classified by WHO pocketbook guidelines (i.e., positive mRDT with any
danger sign, stiff neck, abnormal bleeding, clinical jaundice, or hemoglobinuria).
- Known allergy to penicillin or amoxicillin.
- Receipt of an antibiotic treatment in the 48 hours prior to the study based on
caregiver's self-report and/or documentation in child's medical record.
- Hospitalized within 14 days prior to the study.
- Living outside Lilongwe urban area, the study catchment area.
- Any medical or psychosocial condition or circumstance that, in the opinion of the
investigators, would interfere with the conduct of the study or for which study
participation might jeopardize the child's health.
- Any non-pneumonia acute medical illness which requires antibiotic treatment per local
standard of care.
- Participation in a clinical study of another investigational product within 12 weeks
prior to randomization or planning to begin participation during this study.
- Prior participation in an Innovative Treatments in Pneumonia study during a previous
pneumonia diagnosis.
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