India CLEN Severe Pneumonia Oral Therapy (ISPOT)

This study will determine whether the oral amoxicillin therapy when administered at home is efficacious in comparison to administration of oral amoxicillin for first 48 hours in the hospital in children with severe pneumonia. If this therapy found to be just as successful at homes as it would be for first 48 hours in the hospital, It will be very useful in preventing infections which can be acquired by staying in the hospital and reduces hospitalization costs.

This Study is an open labeled multicentre (4 centers including Chandigarh, Chennai, Nagpur, and Nagpur) prospective two-arm randomized clinical trial to determine the differences in failure of treatment with a 7 day course of oral amoxicillin administered for first 48 hours in the hospital in comparison to being sent home after enrollment, in children 3 to 59 months old who have severe pneumonia.

There is a need to develop/revise guidelines for community management Of Pneumonia in children under five in India and in other developing countries.