Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis

• Status: Completed
• Trial end date: 2019-05-24
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborators: KEMRI-Wellcome Trust Collaborative Research Program; University of Oxford
• Treatments: Ampicillin; Fosfomycin; Gentamicins

Criteria

Inclusion Criteria:

• Age 0 to 28 days inclusive

• Weight >1500g

• Born (an estimated) >34 weeks gestation (calculated as per the Ballard Maturational Assessment)

• Admitted to hospital and eligible to receive IV antibiotics, according to national guidelines

Exclusion Criteria:

• Baseline sodium level >= 150mmol/L

• Baseline creatinine >= 150 micromol/L

• Presenting with severe (grade 3) Hypoxic Ischaemic Encephalopathy (HIE), defined as per Sarnat and Sarnat as a stuporous, flaccid infant (with or without seizure activity) with suppressed brainstem and autonomic functions and absent reflexes

• Requiring cardiopulmonary resuscitation on admission

• Jaundice requiring exchange transfusion

• Admitted as a transfer after an overnight inpatient stay at another hospital

• Known allergy or contraindication to fosfomycin

• A specific clinical indication for another class of antibiotic (other than the nationally recommended standard-of-care)

• More than 4 hours after initiating ampicillin plus gentamicin (one dose), which allows for administration of these first-line antibiotics not to be delayed by study procedures

• Concurrent participation in another clinical trial

• Attending clinician's judgement that the child is so severely ill that adequate communication about the study with the parent or legal guardian is not possible.

• Not planning to remain resident in the County for the next 28 days.

• Lack of consent