Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response (Bact_EVD)
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|ClinicalTrials.gov Identifier: NCT04250168|
Recruitment Status : Terminated (Ebola epidemic in N-Kivu has ended)
First Posted : January 31, 2020
Last Update Posted : August 12, 2020
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.
|Condition or disease|
|Sepsis Bacterial Ebola Virus Disease Bloodstream Infection|
|Study Type :||Observational|
|Actual Enrollment :||43 participants|
|Official Title:||Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment|
|Actual Study Start Date :||November 11, 2019|
|Actual Primary Completion Date :||May 15, 2020|
|Actual Study Completion Date :||June 23, 2020|
- Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients [ Time Frame: 7 months ]Proportion of patients with grown blood cultures versus those who were sampled, spectrum of bacterial species and proportion of antibiotic resistance
- Assess the value of simple biomarker blood tests (WBC + DIFF, CRP, PCT) and Early Warning Scores (EWS) to guide targeted empiric antibiotic treatment and to early detect bacterial bloodstream infections, as compared to bacterial blood culture results [ Time Frame: 7 months ]Relation between score and or biomarker level and growth from blood cultures
- Validate current empiric antibiotic treatment guidelines in EVD care [ Time Frame: 7 months ]Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250168
|Congo, The Democratic Republic of the|
|Ebola Treatment Centers|
|Beni/Mangina, N-Kivu/Ituri, Congo, The Democratic Republic of the|
|institut national de recherche biomedicale(INRB)|
|Kinshasa, Congo, The Democratic Republic of the|
|Principal Investigator:||Octavia Lunguya||INRB|
|Principal Investigator:||Jan Jacobs||ITM|