Funded by WHO | Jan 2006 – Dec 2006
MASS was a multi-country study that conducted community-based trials to demonstrate the safety and efficacy of a home-based oral amoxicillin treatment. Severe pneumonia patients were treated with oral amoxicillin and monitored across five centers in Bangladesh, Bolivia, Egypt, Ghana, and Vietnam. In Bangladesh, patients were enrolled at Dhaka Shishu Hospital and the caregivers were taught how to administer oral doses of the antibiotic.
Acute Respiratory Illnesses are the leading cause of childhood mortality in developing countries and an estimated 2 million under-5 children die each year due to Acute Lower Respiratory Infections. Pneumonia, which kills 1.6 million under-5 children each year, is the leading cause of such ARIs.
In order to reduce ARI related mortality, the World Health Organization developed standardized case management guidelines for treatment. The guidelines recommend use of hospital-based injectable penicillin therapy for treatment of severe pneumonia. However, a large multi-country multicenter randomized trial showed that home-based oral amoxicillin therapy is as effective as injectable penicillin. A home based oral treatment is much easier and cheaper than the alternative and to translate these breakthrough findings into changes in the WHO guidelines, community-based trials demonstrating the safety and efficacy of this treatment, and its geographic university, was required. MASS was designed to do this by treating severe pneumonia patients with oral amoxicillin and monitoring them across five centers in Bangladesh, Bolivia, Egypt, Ghana, and Vietnam.
In Dhaka Shishu Hospital in Bangladesh, 2004 patients were screened and 209 enrolled. These children were given one oral dose of amoxicillin in the hospital and the caregivers were taught how to administer future doses. The children were monitored through community follow-ups. Community health workers followed-up at home on Day 1, 2, 3 and 6 and the final follow-up took place on Day 14 at DSH. If treatment failure was suspected during any of the visits, the patient was referred to hospital. Primary endpoint was treatment failure at any time through day 6. A secondary endpoint was treatment failure between day 6 and day 14. In total, across all sites, 6582 children were screened, 873 were included of whom 823 had recorded outcomes.
The MASS study proved the safety and efficacy of the home-based oral amoxicillin therapy and WHO guidelines now recommend this therapy. It showed that failure rate of this treatment was acceptably low and that this much easier treatment for pneumonia was applicable in a wide variety of settings and geographic locations. These changes have been implemented in the WHO guidelines. Treatment failure across all sites by day 6 was 9.2%, and 2.7% of children who were well on day 6 relapsed by day 14.
- Protocol (Coming soon!)
- CRF (Coming soon!)
- Detailed Results/ graphs/diagrams (Coming soon!)
- Addo-Yobo et al. Outpatient treatment of children with severe pneumonia with oral amoxicillin in four countries: the MASS study. Trop. Med. Int. Health. Aug 2011, 16(8):995-1006. DOI: 10.1111/j.1365-3156.2011.02787.x