Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-30 @ 3:32 AM
Study NCT ID:
NCT04250168
Status:
TERMINATED
Last Update Posted:
2020-08-12
First Post:
2020-01-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
Sponsor:
Institute of Tropical Medicine, Belgium
Organization:
Study Overview
Official Title:
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Ebola epidemic in N-Kivu has ended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Bact_EVD
Brief Summary:
Despite access to experimental Ebola Virus Disease (EVD)-specific treatments, about 30% of patients still die in the Ebola Treatment Centers (ETC) in DRC. There is limited study done about the potential contribution of bacterial co-infections (in particular bloodstream infections) to this adverse outcome, as blood cultures were so far rarely available in epidemic areas. Findings from patients treated in Europe and the USA, and case discussions in the field call for further investigation.
Building further on an ongoing microbiological surveillance project of ITM and INRB in DRC, we are able to set up a research project which will pilot in a standardized manner clinical bacteriology tools (bacterial blood cultures, biomarkers as CRP, procalcitonin and white blood cell differential count, and clinical early warning scores) to study bacterial bloodstream infection in EVD patients in the N-Kivu/Ituri outbreak.
This project will add evidence on 1) frequency, causative pathogen and antibiotic resistance profiles of bacterial bloodstream infections, as well as 2) the predictive value of biomarkers and early warning scores, in EVD patients at different timepoints during hospitalization in an ETC in DRC. The results will inform appropriate antibiotic treatment in an EVD setting and improve patient outcomes.
Building further on an ongoing microbiological surveillance project of ITM and INRB in DRC, we are able to set up a research project which will pilot in a standardized manner clinical bacteriology tools (bacterial blood cultures, biomarkers as CRP, procalcitonin and white blood cell differential count, and clinical early warning scores) to study bacterial bloodstream infection in EVD patients in the N-Kivu/Ituri outbreak.
This project will add evidence on 1) frequency, causative pathogen and antibiotic resistance profiles of bacterial bloodstream infections, as well as 2) the predictive value of biomarkers and early warning scores, in EVD patients at different timepoints during hospitalization in an ETC in DRC. The results will inform appropriate antibiotic treatment in an EVD setting and improve patient outcomes.
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?: