Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

Study Overview
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Brief Summary
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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.

Official Title
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Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment

Conditions
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Sepsis Bacterial, Ebola Virus Disease, Bloodstream Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient admitted in an Ebola Treatment Center (ETC) or Ebola Transit Center (TC) Laboratory-confirmed (Ebola RT-PCR positive result) EVD diagnosis, or, EVD suspect patient requiring instant intravenous antibiotic treatment Willing and able to provide written informed consent personally or by a legally acceptable representative if the patient is unable to do so Exclusion Criteria: We do not exclude certain patient groups, but whenever harm is expected from the additional blood sampling needed for this study, the clinician can opt not to enroll the patient
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients | Proportion of patients with grown blood cultures versus those who were sampled, spectrum of bacterial species and proportion of antibiotic resistance | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Relation between score and or biomarker level and growth from blood cultures | 7 months | 
| Validate current empiric antibiotic treatment guidelines in EVD care | Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ebola Virus Disease, EVD, Bacterial infections, bacteriology, blood cultures, CRP, DR Congo, Antibiotic Resistance, Bacterial bloodstream infection