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A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study

Saturday, 9th of January 2016

A randomized controlled trial of hospital versus home based therapy with oral amoxicillin for severe pneumonia in children aged 3 – 59 months: The IndiaCLEN Severe Pneumonia Oral Therapy (ISPOT) Study

Archana B. Patel, Akash Bang, Meenu Singh, Leena Dhande, Luke Ravi Chelliah, Ashraf Malik, Sandhya Khadse, and ISPOT Study Group

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Abstract below; full text is athttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC4650851/

 

Pneumonia is the single largest killer of children under the age of five worldwide [1]. The disease kills over two million children under the age of five every year— nearly one fourth (400,000) of these deaths occur in India alone [2]. About half of pneumonia cases in India are caused by bacteria and could be treated with antibiotics. However, only 13 % of Indian children under the age of five with suspected pneumonia receive antibiotics [3].

The 2008 WHO guidelines for treatment of non-severe pneumonia (cough, fever and fast breathing) recommend health workers to provide oral antibiotics for three days at home but urgent referral for hospitalization for parenteral (injectable) antibiotics and other supportive therapy after administration of first dose of antibiotics, if the child has severe pneumonia (cough, fever, fast breathing and lower chest indrawing) or very severe disease (pneumonia with the presence of WHO defined danger signs) [4]. Often inability to access a referral facility deprives these children from getting appropriate care. For many families, seeking treatment for their children at a health care facility is often logistically and financially burdensome thus denying them early administration of antibiotics within 48 h that can potentially improve their outcomes. Additionally transport to a distant facility can entail serious delays in effective treatment. Many children with severe pneumonia referred for admission to a hospital could die in transit or reach too sick to be saved [5]. In addition, when hospitalized, the children with severe pneumonia are vulnerable to nosocomial infections in crowded hospital wards and are also at risk of needle-borne infections due to parenteral therapy. Two important studies have addressed such barriers to the recommended treatment of severe pneumonia. The first study was intended to determine whether oral antibiotics are equivalent to injectable antibiotics when both are given in the hospital. This was an open label equivalency study called APPIS (Amoxicillin Penicillin Pneumonia International Study), which was a large multicentre randomized controlled trial comparing injectable penicillin versus oral amoxicillin given for 7 days to children in the hospital [6]. The second study was called “NO-SHOTS” (New Outpatient Short-Course Home Oral Therapy for Severe Pneumonia Study) and was a randomized, open-label equivalency trial done at seven study sites in Pakistan and compared initial hospitalization and parenteral ampicillin for 48 h followed by 3 days of oral amoxicillin at home, to 5 days of home-based treatment with oral amoxicillin [7]. NO-SHOTS showed that home treatment with high-dose oral amoxicillin is equivalent to hospital based treatment with parenteral ampicillin in selected children aged 3–59 months with WHO defined severe pneumonia [7]. Later, another study- the MASS study (Multicenter Amoxicillin Severe pneumonia Study) showed that 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 (Bangladesh, Ghana, Vietnam and Egypt) and hence home-based therapy of severe pneumonia could possibly be applied to a wide variety of settings [8]. Thus oral amoxicillin at home has proven clinically efficacious in various settings across the world for treatment of selected children with WHO defined severe pneumonia. The Lancet Series on Childhood Pneumonia and Diarrhoea has reported that case management is one of the three most effective interventions to reduce pneumonia deaths in children but also noted that the cost effectiveness of these interventions in national health systems needs urgent assessment [9]. So the cost savings or cost-effectiveness of home-based oral antibiotic treatment for WHO defined severe pneumonia in childhood would be important to inform public policy and has not been previously evaluated.

Therefore our objective was to assess the efficacy and cost-effectiveness of a 7-day home-based course of oral amoxicillin as compared to oral amoxicillin administered for the first 48 h in the hospital followed by 5 days of home-administration.