Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response

Ebola Virus Disease Clinical Trial

— Bact_EVD  

Official title:

Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04250168
• Other study ID #: 1328/19
• Status: Terminated
• Start date: November 11, 2019
• Est. completion date: June 23, 2020

Study information

• Verified date: February 2020
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 43
• Est. completion date: June 23, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Ebola Virus Disease
• Hemorrhagic Fever, Ebola
• Infection
• Sepsis Bacterial
• Virus Diseases

Locations

Country	Name	City	State
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

Sponsors (6)

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

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Relation between score and or biomarker level and growth from blood cultures	7 months
Secondary	Validate current empiric antibiotic treatment guidelines in EVD care	Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections	7 months