| Fast breathing for age | Respiratory rate >50 breaths per minute for children t2 to <12 months of age, or >40 breaths per minute for children>12 months of age |
| Severe respiratory distress | Grunting, nasal flaring, head nodding and/or chest indrawing |
| Hypoxaemia | Arterial oxyhaemoglobin saturation (SpO2) <90% in room air, as assessed non-invasively by a pulse oximeter |
| WHO IMCI general danger signs | Lethargy or unconsciousness, convulsions, vomiting everything or inability to drink or breastfeed |
| Severe acute malnutrition | Weight for height/length <-3 SD, MUAC <11.5 cm, or peripheral oedema |
| Severe malaria | Positive malaria rapid diagnostic test with any WHO IMCI general danger sign, stiff neck, abnormal bleeding, clinical jaundice, or haemoglobinuria |
| HIV 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 hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity Is a medical event, based on appropriate medical judgement, that may jeopardise the health of the participating child or require medical or surgical intervention to prevent one of the outcomes listed
|
| Eligibility criteria |
| Inclusion criteria | |
| Exclusion criteria | Severe respiratory distress Hypoxaemia Resolution of fast-breathing after bronchodilator challenge, if wheezing at screening examination WHO IMCI general danger signs Stridor when calm HIV seropositivity or HIV exposure Severe acute malnutrition Possible tuberculosis (coughing >14 days) Anaemia with haemoglobin <80 g/L Severe malaria Known allergy to penicillin or amoxicillin Receipt of an antibiotic treatment in the 48 hours prior to the study Hospitalised 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 jeopardise the child’s health Any non-pneumonia acute medical illness which requires antibiotic treatment as per local standard of care Participation in a clinical study of another investigational product within 12 weeks prior to randomisation or planning to begin participation during this study Prior participation in the study during a previous pneumonia diagnosis
|
| Treatment failure |
| Any time on or before day 4 | Severe respiratory distress Hypoxaemia WHO IMCI danger signs Missing >2 study drug doses due to vomiting Change in antibiotics prescribed by a study clinician Hospitalisation due to pneumonia (if not initially admitted) Prolonged hospitalisation or re-admission due to pneumonia (if initially admitted) Death
|
| On day 4 only | |
| Clinical relapse | |
| Any time after day 4 | |
| NIH DAIDS severity grading |
| Grade 1 | Mild event |
| Grade 2 | Moderate event |
| Grade 3 | Severe event |
| Grade 4 | Potentially life-threatening event |
| Grade 5 | Death |