Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

NCT04250168 | Terminated

• 1 other identifier: 1328/19
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 2

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.

Conditions

Sepsis Bacterial; Ebola Virus Disease; Bloodstream Infection

Keywords

Ebola Virus Disease; EVD; Bacterial infections; bacteriology; blood cultures; CRP; DR Congo; Antibiotic Resistance; Bacterial bloodstream infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  7 months

• Validate current empiric antibiotic treatment guidelines in EVD care

  7 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead
• Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo: collaborator
• Alliance for International Medical Action: collaborator
• Médecins Sans Frontières, France: collaborator
• International Medical Corps: collaborator
• World Health Organization: collaborator

Study Sites (2)

Ebola Treatment Centers

Beni/Mangina, N-Kivu/Ituri, Democratic Republic of the Congo

Location

institut national de recherche biomedicale(INRB)

Kinshasa, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Sepsis; Bacterial Infections

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses

Study Officials

• Octavia Lunguya

  INRB

  PRINCIPAL INVESTIGATOR

• Jan Jacobs

  ITM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: November 11, 2019
• Primary Completion: May 15, 2020
• Study Completion: June 23, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-02

Locations

DE (2)