Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response (Bact_EVD)

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

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.

Study Overview

• Status: Terminated
• Conditions: Ebola Virus Disease; Bloodstream Infection; Sepsis Bacterial

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• Congo, The Democratic Republic of the
  • Kinshasa, Congo, The Democratic Republic of the
    • institut national de recherche biomedicale(INRB)
  • N-Kivu/Ituri
    • Beni/Mangina, N-Kivu/Ituri, Congo, The Democratic Republic of the
      • Ebola Treatment Centers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of laboratory confirmed EVD patients admitted to the Ebola Treatment Centers (ETCs) in N-Kivu & Ituri province and participating in the study. As broad-spectrum antibiotics are often started as soon as patients arrive in the suspect area of the ETC or transit center, and as this might interfere with bacterial bloodstream infection detection in blood cultures, patients can be included from the stage of being 'a probable suspect' onwards in some instances (i.e. prior to start-up of broad-spectrum antibiotics, clinical suspicion of bacterial bloodstream infection at admission in suspect area, etc).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Tropical Medicine, Belgium
• Collaborators: World Health Organization; Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo; Alliance for International Medical Action; Médecins Sans Frontières, France; International Medical Corps
• Investigators: Principal Investigator: Octavia Lunguya, INRB; Principal Investigator: Jan Jacobs, ITM

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 11, 2019
• Primary Completion (ACTUAL): May 15, 2020
• Study Completion (ACTUAL): June 23, 2020

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: January 29, 2020
• First Posted (ACTUAL): January 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Bacterial infections; CRP; Antibiotic Resistance; blood cultures; Ebola Virus Disease; DR Congo; EVD; bacteriology; Bacterial bloodstream infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Mononegavirales Infections; Hemorrhagic Fevers, Viral; Filoviridae Infections; Sepsis; Infections; Communicable Diseases; Virus Diseases; Hemorrhagic Fever, Ebola
• Other Study ID Numbers: 1328/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No