Outpatient treatment of children with severe pneumonia with oral amoxicillin in four countries: the MASS study

OBJECTIVE A recent randomized clinical trial demonstrated home-based treatment of WHO-defined severe pneumonia with oral amoxicillin was equivalent to hospital-based therapy and parenteral antibiotics. We aimed to determine whether this finding is generalizable across four countries. METHODS Multicentre observational study in Bangladesh, Egypt, Ghana and Vietnam between November 2005 and May 2008. Children aged 3-59 months with WHO-defined severe pneumonia were enrolled at participating health centres and managed at home with oral amoxicillin (80-90 mg/kg per day) for 5 days. Children were followed up at home on days 1, 2, 3 and 6 and at a facility on day 14 to look for cumulative treatment failure through day 6 and relapse between days 6 and 14. RESULTS Of 6582 children screened, 873 were included, of whom 823 had an outcome ascertained. There was substantial variation in presenting characteristics by site. Bangladesh and Ghana had fever (97%) as a more common symptom than Egypt (74%) and Vietnam (66%), while in Vietnam, audible wheeze was more common (49%) than at other sites (range 2-16%). Treatment failure by day 6 was 9.2% (95% CI: 7.3-11.2%) across all sites, varying from 6.4% (95% CI: 3.1-9.8%) in Ghana to 13.2% (95% CI: 8.4-18.0%) in Vietnam; 2.7% (95% CI: 1.5-3.9%) of the 733 children well on day 6 relapsed by day 14. The most common causes of treatment failure were persistence of lower chest wall indrawing (LCI) at day 6 (3.8%; 95% CI: 2.6-5.2%), abnormally sleepy or difficult to wake (1.3%; 95% CI: 0.7-2.3%) and central cyanosis (1.3%; 95% CI: 0.7-2.3%). All children survived and only one adverse drug reaction occurred. Treatment failure was more frequent in young infants and those presenting with rapid respiratory rates. CONCLUSIONS Clinical treatment failure and adverse event rates among children with severe pneumonia treated at home with oral amoxicillin did not substantially differ across geographic areas. Thus, home-based therapy of severe pneumonia can be applied to a wide variety of settings.