Design-Stage Trial of Gentamicin in the Uniject Device

in Community Health, wrote: “To further simplify the parenteral administration of gentamicin, theuse of disposable syringes prefilled with gentamicin, or a single-use simple Uniject device should betested.” 21There are many identifiable advantages for administering gentamicin in Uniject for treatment ofneonatal sepsis in developing countries. Some of those advantages include the following:• Home use may improve timing. Uniject devices are small, easy to transport, and can beadministered by minimally trained health workers. These features may improve the timing ofadministering the first dose—and possibly subsequent doses—of antibiotics by improvingaccessibility within the home or first-line health facility. To decrease the case-fatality rate, it iscritically important to deliver the first dose of antibiotics as close to the onset of infection aspossible. Often, waiting until the infant reaches the referral center may be too late.• Sterile injections. The Uniject device, a nonreusable injection device with a fixed needle,eliminates the possibility of reuse. The design of the packaging also decreases the likelihoodthat the device will become contaminated before the injection is administered. These designfeatures will help ensure sterility of the needle and safety of the injection, thereby eliminatingrisk of transmission of blood-borne agents—notably HIV, hepatitis B, and hepatitis C—whileminimizing risk of local infections at the injection site.• Accurate prefilled dose. Uniject devices are produced with an accurate volume of a specifieddose. This reduces the possibility for a health worker to accidentally administer too much or toolittle antibiotic. However, the preset dose would make it more difficult than using standardsyringes to calibrate and deliver the exact dose per body weight.• Stability. Because gentamicin is stable at ambient temperatures, gentamicin in Uniject does notneed refrigeration and can be transported and stored at room temperature (the stability ofgentamicin packaged in the Uniject device was verified in a pilot study prior to initiation of thefield study).• Simplified logistics. Since the antibiotic and syringe are incorporated into the Uniject device,logistical issues are simplified and stockouts due to insufficient supply of components such assyringes or medication are minimized. Furthermore, the inclusive design of the Uniject devicealso means that no other equipment—except for a safety disposal box—is required to administerinjections in the field or at the health facility.Home-based and primary health facility use of gentamicin in Uniject is considered highly feasiblebased on PATH’s experience in introducing the Uniject device in various developing countries. 12-14,17-20,222.5 Dosing for gentamicin in UnijectPATH, in collaboration with Johns Hopkins University, undertook a pharmacokinetic study withfunding from Saving Newborn Lives to determine safe and effective dosing regimens of gentamicinfor use in the Uniject device to treat neonatal sepsis in developing countries. In the study, neonatesFinal Report(10) Gentamicin in Uniject: A Feasibility Study