Clinical trial NCT04250168: Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
Official title: Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
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
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche Biomédicale. Kinshasa, République Démocratique du Congo
name: Alliance for International Medical Action
name: Médecins Sans Frontières, France
name: International Medical Corps
name: World Health Organization
First posted: 2020-01-31
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients
timeFrame: 7 months
Secondary outcomes:
measure: 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
timeFrame: 7 months
measure: Validate current empiric antibiotic treatment guidelines in EVD care
timeFrame: 7 months
Other outcomes:
Locations:
city: Beni/Mangina
country: Congo, The Democratic Republic of the
facility: Ebola Treatment Centers
state: N-Kivu/Ituri
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: institut national de recherche biomedicale(INRB)
Study officials:
affiliation: INRB
name: Octavia Lunguya
role: PRINCIPAL_INVESTIGATOR
affiliation: ITM
name: Jan Jacobs
role: PRINCIPAL_INVESTIGATOR
References: