Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
Status:
Completed
Trial end date:
2019-05-24
Target enrollment:
Participant gender:
Summary
Neonatal sepsis has a high risk of morbidity and mortality. The current WHO and national
guidelines recommend antibiotics to which resistance is reported in neonatal populations,
although the available data is limited. Research on alternative empirical regimens for
neonatal sepsis which are affordable, safe and cost-effective, with a step-down oral option,
is needed. AMR is an issue of global public health concern and is one of the WHO's global
health priority areas. Understanding the benefits, risks, MIC capacity and PK of fosfomycin
will influence global policy on the case management of neonates with sepsis in Kenya and
international settings.
Phase:
Phase 2
Details
Lead Sponsor:
Drugs for Neglected Diseases
Collaborators:
KEMRI-Wellcome Trust Collaborative Research Program University of Oxford