| Study definitions |
| Chest-indrawing pneumonia |
Cough less than 14 days or difficulty breathing AND visible
indrawing of the chest wall with or without fast breathing for age |
| Non-severe fast-breathing pneumonia |
Cough less than 14 days or difficulty breathing AND fast breathing
for age |
| Fast breathing for age |
Respiratory rate >50 breaths per minute (for children 2 to
<12 months of age) or >40 breaths per minute (for children
>12 months of age) |
| Very fast breathing for age |
>70 breaths per minute (for children 2 to <12 months
of age) or >60 breaths per minute (for children >12 months of
age). |
| Severe respiratory distress |
Grunting, nasal flaring, head nodding, and/or chest indrawing |
| Hypoxemia |
Arterial oxyhemoglobin saturation (SpO2) < 90% in room air,
as assessed non-invasively by a pulse oximeter |
| World Health Organization (WHO) Integrated Management of Childhood
Illness (IMCI) general danger signs |
Lethargy or unconsciousness, convulsions, vomiting everything,
inability to drink or breastfeed |
| Severe acute malnutrition |
Weight for height/length < -3 SD, mid-upper arm
circumference (MUAC) <11·5 cm, or peripheral edema |
| Severe malaria |
Positive malaria rapid diagnostic test (mRDT) with any WHO IMCI
general danger sign, stiff neck, abnormal bleeding, clinical jaundice, or
hemoglobinuria |
| HIV-1 exposure |
Children <24 months of age with a HIV-infected mother |
| Serious adverse event |
Adverse event that:
Results in death Is life threatening Requires inpatient hospitalization or prolongation of existing
hospitalization Results in persistent or significant disability/incapacity Is a medical event, based on appropriate medical judgment, that may
jeopardize the health of the participating child or require medical or
surgical intervention to prevent 1 of the outcomes listed
|
| Eligibility criteria |
| Inclusion criteria |
2-59 months of age Cough <14 days or difficulty breathing Visible indrawing of the chest wall with or without fast breathing for
age Ability and willingness of child’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 for a
scheduled study follow-up visit |
| Exclusion criteria |
Severe respiratory distress Hypoxemia Resolution of chest indrawing after bronchodilator challenge, if wheezing
at screening examination WHO IMCI general danger signs Stridor when calm HIV-1 seropositivity or HIV-1 exposure Severe acute malnutrition Possible tuberculosis (coughing for more than 14 days) Severe anemia (hemoglobin <8.0 g/dL) Severe malaria Known allergy to penicillin or amoxicillin Receipt of an antibiotic treatment in the 48 hours prior to the study Hospitalized within 14 days prior to the study Living outside the study 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 the study during a previous pneumonia diagnosis |
| Treatment failure |
| Anytime on or before Day 6 |
Severe respiratory distress Hypoxemia WHO IMCI danger signs Missing >3 study drug doses due to vomiting Change in antibiotics prescribed by a study clinician Prolonged hospitalization or re-admission due to pneumonia Death |
| At or after initial hospitalization discharge (between 42 and 60
hours post-enrollment) |
|
| On Day 6 |
|
| Relapse |
| After Day 6 |
Recurrence of signs of chest-indrawing pneumonia, severe respiratory
distress (e.g., grunting, nasal flaring, head nodding, or severe chest
indrawing) or severe disease
|
