TPP: For therapy in children including neonates with multidrug-resistant gram-negative infections
Target product profile for therapy of neonatal sepsis in high resistance settings
1 January 2020
Indication
Serious bacterial infections in environments with high prevalence of XDR Gram-negative bacteria for which there are limited or no treatment options, and neonatal sepsis/meningitis
caused by MDR and XDR Gram-negative pathogens, including K. pneumoniae and Acinetobacter spp., failing on optimal current treatment.
Intended use
Treatment intended against infections caused by MDR and XDR Gram-negative pathogens, including K. pneumoniae and Acinetobacter spp., failing on optimal current treatment.
Target population
Hospitalized children including neonates with severe infections, failure on current
treatment and a very high likelihood of being caused by MDR/XDR Gram-negative pathogens.
Sample type and volume
Injectable and oral formulations
Use setting
To be used in areas with high prevalence of MDR and XDR Gram-negative pathogens, including K. pneumoniae and Acinetobacter spp.
Performance
In-vitro activity against MDR and XDR Gram-negative pathogens, including K. pneumoniae
and Acinetobacter spp., activity tested in bacteria with defined resistance mechanisms (especially β-lactams,aminoglycosides, fosfomycin) and clinical strains, especially carbapenem-resistant strains, no cross-resistance to currently used antibiotics. Low propensity for resistance development.
Efficacy
Proven efficacy in adults, and showing safety and refining the PK in neonates and children.
Demonstrate clinical efficacy in adults with confirmed XDR infections.
Safety
The need for safety and tolerability data from animal juvenile toxicity models should be considered on a case-by-case basis. No requirement to routinely monitor drug levels.
Contact email
Product type
Drug
Status
Active
Safety
ID_219