A randomized open labeled parallel group phase III study of antibiotics alone versus antibiotics plus granulocyte-colony-stimulating factor in pediatric patients with chemotherapy induced febrile neutropenia in a developing country.

Chemotherapy causes neutropenia (low white cell count), which leads to infections and death.Human granulocytegrowth factors (GCSF) are used to increase the low white blood cell count after chemotherapy.GCSF has been shown to be useful in reducing the duration of fever with neutropenia, duration of antibiotic use and duration of hospital stay in adults in developing countries. The morbidity and mortality associated with febrile neutropenia is higher in developing countries with much higher ambient infectious burden, crowding, poor nutrition, suboptimal infection control practices,and limited human resource and intensive care infrastructure required for care of such patients.It is likely that the benefit of reduction in the days of febrile neutropenia may be much more in developing countries and may be much more cost effective compared to developed countries. There is currently no published well conducted randomized study addressing the role of GCSF in febrile neutropenia in children in developing countries.Therefore,we attempt to determine whether GCSF administered in addition to empiric antibiotic therapy is beneficial as well as cost -effective in febrile neutropenic pediatric patients in developing countries.