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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250168
Recruitment Status : Terminated (Ebola epidemic in N-Kivu has ended)
First Posted : January 31, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Institute of Tropical Medicine, Belgium

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
Sepsis Bacterial Ebola Virus Disease Bloodstream Infection

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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 : November 11, 2019
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : June 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Ebola




Primary Outcome Measures :
  1. Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients [ Time Frame: 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 :
  1. 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 [ Time Frame: 7 months ]
    Relation between score and or biomarker level and growth from blood cultures

  2. Validate current empiric antibiotic treatment guidelines in EVD care [ Time Frame: 7 months ]
    Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250168


Locations
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Congo, The Democratic Republic of the
Ebola Treatment Centers
Beni/Mangina, N-Kivu/Ituri, Congo, The Democratic Republic of the
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
Investigators
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Principal Investigator: Octavia Lunguya INRB
Principal Investigator: Jan Jacobs ITM
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Responsible Party: Institute of Tropical Medicine, Belgium
ClinicalTrials.gov Identifier: NCT04250168    
Other Study ID Numbers: 1328/19
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institute of Tropical Medicine, Belgium:
Ebola Virus Disease
EVD
Bacterial infections
bacteriology
blood cultures
CRP
DR Congo
Antibiotic Resistance
Bacterial bloodstream infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Virus Diseases
Hemorrhagic Fever, Ebola
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections