Neonatal Diseases
Conditions
Interventions
Next generation sequencing
Sponsors
Makerere University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For this study, we plan to recruit cases that a highly likely to be sepsis and that will include babies with a very high suspicion index of sepsis including clinical signs of severe illness (lethargy, hypothermia, fever, severe chest indrawing, convulsions)
Exclusion criteria
Exclusion criteria: We will exclude babies i) whose caretakers do not provide informedd consent ii) with severe congenital anomalies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints 1.The proportion of neonates with a possible bloodstream infection with culture-negative sepsis in whom (a) pathogen(s) is identified using NGS 2.The proportion of neonates with a possible bloodstream infection in whom a potentially causative organism is identified using blood culture versus the proportion of neonates with possible bloodstream infection in whom (a) pathogen(s) is identified with NGS 3.The sensitivity and specificity of Blood Culture and NGS in identifying (a) pathogen(s) of possible bloodstream infection compared to a composite reference standard (consisting of all microbiological tests and clinical adjudication)1.Case fatality risk of sepsis among neonates with possible bloodstream infection admitted at Kawempe national referral hospital. Case fatality risk will be defined as the proportion of neonates who die among those with bloodstream infections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Case fatality risk | — |
Countries
Uganda
Contacts
Public ContactEvalyne Tusiimirwe
Study coordinator and Admin
Outcome results
None listed