TABLE 2

Treatment failure criteria and hospital discharge criteria

Treatment failure criteria
  • Any time on or before day 4:

     Severe respiratory distress

     Hypoxaemia

     WHO IMCI general 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:

     Axillary temperature ≥38°C in the absence of a diagnosed co-infection with fever symptoms (e.g. malaria)

Hospital discharge criteria
  • None of the criteria for treatment failure are present:

     WHO IMCI danger signs

     Severe respiratory distress, hypoxaemia, chest indrawing

     Vomiting within 30 min of two or more doses of study product

     Change in antibiotics prescribed by a study clinician (e.g. switch to a   second-line antibiotic or prescription for onset of a co-infection)

     Death

WHO: World Health Organization; IMCI: Integrated Management of Childhood Illnesses.