A double blind community-based randomized trial of amoxicillin versus placebo for fast breathing pneumonia in children aged 2-59 months in Karachi, Pakistan (RETAPP)

Table 1 Eligibility Criteria

Inclusion	Exclusion
Children 2–59 months old who are visiting PHC History of cough or difficult breathing less than 14 days^a (observed or reported) Respiratory rate ≥ 50 breaths per minute in children 2 to <12 months OR respiratory rate ≥ 40 breaths per minute in children ≥12 months^b Providing written informed consent	Antibiotics taken in last 48 h Lower chest wall in-drawing Any general danger sign as defined by WHO (Stridor when calm, hypoxia defined as SaO ₂ < 90 % in air, inability to feed, persistent vomiting, convulsions or reduced conscious level) Bulging fontanel Pedal edema Known asthmatics, tuberculosis or other severe illness History of hospitalization in last two weeks Congenital heart disease Any surgical condition requiring hospitalization Out of catchment area Enrolled in another trial or previously enrolled in study

^aChildren, who present with wheeze along with cough or difficulty in breathing, are given trial of nebulization with bronchodilator up to three times 15–20 min apart. These children are then re-assessed for respiratory rate after each nebulization therapy. If respiratory rate remains persistently above cut-off, irrespective of wheeze, child is considered for inclusion. For persistent wheezers, oral bronchodilator is given for three days
^bOn two consecutive readings by community health worker and physicians

ISSN: 1471-2334