Outpatient Treatment of Neonatal Sepsis by the Rectal Administration of Gentamicin

Organization: 
PATH
Organization Location: 
Seattle, WA, USA

Neonatal sepsis is a major cause of infant mortality in low-resource areas. While intramuscular antibiotic treatment regimens have been shown to be effective and safe, access to these treatments are limited to areas serviced by higher level healthcare workers, trained and approved to administer injections to infants. We propose to investigate the feasibility of a needle-free method of administration for the antibiotic gentamicin via the rectal route. Under this project we would conduct laboratory release studies, preclinical rectal bioavailability studies and stakeholder interviews to assess the feasibility of novel concept. This delivery method would improve access to outpatient treatment of neonatal sepsis in areas serviced by low level healthcare providers and would remove the inherent risks associated with parenteral delivery. This concept is particularly novel in that the target antibiotic, gentamicin is, currently, only administered by parenteral routes and cannot be delivered orally. By applying innovative formulation technology, we hope to provide therapeutically equivalent pediatric doses of gentamicin using a simplified, more accessible route of delivery.

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