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

Institute of Tropical Medicine, Belgium

Status: Terminated

Conditions: Ebola Virus Disease; Bloodstream Infection; Sepsis Bacterial

Study type: Observational

Funder types: Other

Identifiers

NCT04250168

1328/19

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Volunteers: No Healthy Volunteers

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