Sepsis BacterialBact_EVDNCT04250168
Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response
An observational study of Sepsis Bacterial and Ebola Virus Disease, run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis Bacterial, Ebola Virus Disease, Bloodstream Infection
- How many people
- 43 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- 11 Nov 2019to 23 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
Ebola Treatment Centers
Beni/Mangina, N-Kivu/Ituri
institut national de recherche biomedicale(INRB)
Kinshasa
About this study
Official title: Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment
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.
- 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
- Medical subject headings
- Hemorrhagic Fever, Ebola, Sepsis, Bacterial Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 months
Secondary outcomes (2)
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
Measured: 7 months
Validate current empiric antibiotic treatment guidelines in EVD care
Proportion of cases for which empiric antibiotic covered the bacteria causing bloodstream infections
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start11 Nov 2019
- Primary completion15 May 2020
- Study completion23 Jun 2020
Why it stopped: Ebola epidemic in N-Kivu has ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Alliance for International Medical Action, Médecins Sans Frontières, France, International Medical Corps, World Health Organization
- Responsible party
- Sponsor
- Investigators
- Octavia Lunguya, Principal investigator, Institut National de Recherche Biomedicale (INRB)Jan Jacobs, Principal investigator, ITM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250168
- Sponsor's protocol ID
- 1328/19
- Acronym
- Bact_EVD
- Status last verified
- Feb 2020
- First submitted
- 29 Jan 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting Clinical Bacteriology in the Ebola Virus Disease Care Response to Detect Intercurring Bloodstream Infections and Inform Appropriate Antibiotic Treatment
- ClinicalTrials.gov ID
- NCT04250168
- Acronym / sponsor ID
- Bact_EVD / 1328/19
- Conditions
- Sepsis Bacterial, Ebola Virus Disease, Bloodstream Infection
- Keywords
- Ebola Virus Disease, EVD, Bacterial infections, bacteriology, blood cultures, CRP, DR Congo, Antibiotic Resistance
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Ebola epidemic in N-Kivu has ended
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut National de Recherche Biomedicale (INRB), Alliance for International Medical Action, Médecins Sans Frontières, France, International Medical Corps, World Health Organization
- Study start
- 11 Nov 2019 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Validate current empiric antibiotic treatment guidelines in EVD care
Time frame: 7 months
Results and safety
The study was stopped early (reason given: Ebola epidemic in N-Kivu has ended). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Octavia Lunguya principal investigator
Institut National de Recherche Biomedicale (INRB)
Jan Jacobs principal investigator
ITM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Bacterial and Ebola Virus Disease, run by Institute of Tropical Medicine, Belgium at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Ebola epidemic in N-Kivu has ended). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine frequency, causative pathogen, and antibiotic resistance profiles of bacterial bloodstream infections among confirmed EVD patients (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2020.