Ignite Creation Date:
2024-05-06 @ 11:11 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03453177
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2018-02-07
Brief Title:
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
Sponsor:
Drugs for Neglected Diseases
Organization:
Drugs for Neglected Diseases
Study Overview
Official Title:
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis an Open-label Safety and Pharmacokinetics Study neoFosfo
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NeoFosfo
Brief 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 WHOs 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
Detailed Description:
Antimicrobial resistance AMR has become a major issue in global health Despite progress in the reduction of under 5 mortality rates in recent decades the proportion of neonatal deaths occurring within this age group has increased with almost one quarter of all neonatal deaths occurring due to serious bacterial infection Common bacteria causing neonatal sepsis are now exhibiting widespread resistance to several classes of antibiotics There is an urgent need to discover new effective treatments and re-evaluate existing therapeutic agents to treat infections potentially caused by multi-drug resistant MDR pathogens Gram-negative bacteria GNB predominate as the cause of neonatal sepsis and are increasingly associated with high rates of resistance to the currently recommended WHO empirical therapy regimen of ampicillinpenicillin and gentamicin There is therefore a need to develop an updated empiric regimen with improved efficacy in the context of increasing MDR sepsis in neonates New antimicrobials under development will be expensive once licensed and there are currently virtually no planned trials to assess their efficacy in neonates in low- and middle-income countries LMICs
One potential strategy is utilising an existing off-patent and therefore affordable antibiotic available in intravenous and oral formulations - fosfomycin Fosfomycin has a wide spectrum of activity against Gram-positive and Gram-negative bacteria causing neonatal sepsis It is mainly used for resistant urinary tract infections in adults but has licenced neonatal and paediatric doses in Europe though dosing regimens vary between countries Both oral and IV formulations are available A large clinical trial to assess the efficacy of a fosfomycin plus an aminoglycoside combination compared to the current WHO recommended ampicillin and gentamicin is anticipated including sites in Kenya The ultimate aim is for fosfomycin to be included in the WHO Essential Medicines List for children EMLc and be available for use in developing countries where rates of resistance to ampicillin and gentamicin have been estimated at over 40 The first steps before this trial are to clarify the pharmacokinetics PK and safety profile of fosfomycin in neonates as well as generating further information regarding local patterns of bacterial susceptibility to fosfomycin The aim of this study is to fulfil both these steps Fosfomycin IV and oral PK will be investigated among 60 babies admitted to hospital and being treated for presumed sepsis administered alongside the standard antibiotics Another 60 babies receiving standard treatment only without PK sampling will be monitored in the same way to compare adverse events In the laboratory at CGMR-C previously archived bacterial isolates will be tested for their sensitivity to fosfomycin
One potential strategy is utilising an existing off-patent and therefore affordable antibiotic available in intravenous and oral formulations - fosfomycin Fosfomycin has a wide spectrum of activity against Gram-positive and Gram-negative bacteria causing neonatal sepsis It is mainly used for resistant urinary tract infections in adults but has licenced neonatal and paediatric doses in Europe though dosing regimens vary between countries Both oral and IV formulations are available A large clinical trial to assess the efficacy of a fosfomycin plus an aminoglycoside combination compared to the current WHO recommended ampicillin and gentamicin is anticipated including sites in Kenya The ultimate aim is for fosfomycin to be included in the WHO Essential Medicines List for children EMLc and be available for use in developing countries where rates of resistance to ampicillin and gentamicin have been estimated at over 40 The first steps before this trial are to clarify the pharmacokinetics PK and safety profile of fosfomycin in neonates as well as generating further information regarding local patterns of bacterial susceptibility to fosfomycin The aim of this study is to fulfil both these steps Fosfomycin IV and oral PK will be investigated among 60 babies admitted to hospital and being treated for presumed sepsis administered alongside the standard antibiotics Another 60 babies receiving standard treatment only without PK sampling will be monitored in the same way to compare adverse events In the laboratory at CGMR-C previously archived bacterial isolates will be tested for their sensitivity to fosfomycin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None