Bact_EVD: Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

Sponsor

Institute of Tropical Medicine, Belgium (Other)

Overall Status

Terminated

CT.gov ID

NCT04250168

Collaborator

Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo (Other), Alliance for International Medical Action (Other), Médecins Sans Frontières, France (Other), International Medical Corps (Other), World Health Organization (Other)

Enrollment

Locations

7.4

Actual Duration (Months)

21.5

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis Bacterial Ebola Virus Disease Bloodstream Infection

Study Design

Study Type:

Observational

Actual Enrollment :

43 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Nov 11, 2019

Actual Primary Completion Date :

May 15, 2020

Actual Study Completion Date :

Jun 23, 2020

Outcome Measures

Primary Outcome Measures

Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients [7 months]
Proportion of patients with grown blood cultures versus those who were sampled, spectrum of bacterial species and proportion of antibiotic resistance

Secondary Outcome Measures

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]
Relation between score and or biomarker level and growth from blood cultures
Validate current empiric antibiotic treatment guidelines in EVD care [7 months]
Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ebola Treatment Centers	Beni/Mangina	N-Kivu/Ituri	Congo, The Democratic Republic of the
2	institut national de recherche biomedicale(INRB)	Kinshasa		Congo, The Democratic Republic of the

Sponsors and Collaborators

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