SepsisSICKNCT05139459
Sepsis Characterization in Kilimanjaro
An observational study of Sepsis, run by Duke University at 1 site in United States.
Trial summary
The aim of this study is to prospectively evaluate the barriers to care, evaluation, clinical practices, and outcomes for patients presenting with sepsis to hospitals in the Kilimanjaro Region of northern Tanzania. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Sepsis
- How many people
- 499 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2022to 3 Nov 2023
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adolescent and adult patients with sepsis presenting to emergency department or outpatient department at hospitals in Kilimanjaro Region, northern Tanzania.
Who may be able to join
- Persons ≥ 10 years of age presenting to hospital suspected to have an infection and meeting two of the following vital signs criteria:
- tympanic >38°C or < 36°C
- a heart rate > 90 beats per minute
- a respiratory rate of > 20 breaths per minute
Who cannot join
- patient with a language barrier
- pregnant female
- a refugee
- a prisoner
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Centre
Durham, North Carolina, 27706
About this study
Official title: Sepsis in Sub-Saharan Africa: a Prospective Observational Study of Clinical Characteristics, Management, Outcomes, and Barriers to Care in Northern Tanzania
The aim of this study is to prospectively evaluate the barriers to care, evaluation, clinical practices, and outcomes for patients presenting with sepsis to hospitals in the Kilimanjaro Region of northern Tanzania. This will include an assessment of timing and selection of antimicrobials and administration and volume of intravenous fluids. The study also aims to characterize sepsis sub-types in the epidemiologic context of northern Tanzania using statistical clustering techniques of clinical variables and of host immune response patterns.
Read the detailed description
A prospective observational cohort study of adolescent and adult patients with sepsis presenting to hospitals in the Kilimanjaro Region, Tanzania. Participants ≥10 years of age with suspected infection and the presence of two of the following will be enrolled: (1) tympanic temperature > 38°C or < 36°C, (2) heart rate > 90 beats/minute, (3) respiratory rate > 20 breaths/minute. Participants will be observed in the Emergency Department and during admission. The following data will be collected: demographics and medical history; history of present illness; laboratory and microbiological workup; antimicrobial selection and timing; intravenous fluid timing and volume. Vital status will be determined at 7 days, hospital discharge, and 28 days post-presentation. An enrollment of up to 1250 patients with sepsis is expected over a two-year period.
This study is expected to produce additional descriptive data of sepsis epidemiology and current practice in sSA. The data will yield important insights regarding key care practices for sepsis, including antimicrobial and intravenous fluid management. Outcomes of patients with sepsis will be described, including an assessment for correlations between current care practices and mortality.
Characterization of potential sepsis sub-types will be undertaken in two domains: 1) clinical characterization via a robust battery of routine clinical laboratories (chemistry, hematology, coagulation studies), vital signs, routine clinical signs and anthropometry; 2) host immune response characterization by analysis of mRNA transcriptome expression in RNA-stabilized whole blood samples. The goal of the sub-type characterization is to identity discrete and clinically relevant sepsis phenotypes, and in doing so eventually help optimize evaluation and management of sepsis specific to the populations and health systems in sub-Saharan Africa. Detailed etiologic investigations will also take place, including blood culture, blood parasite smears, and viral respiratory testing of nasopharyngeal samples; for patients living with HIV, additional evaluations will include serum cryptococcal antigen, urine lipoarabinomannan assay (TB-LAM) and MycoFLytic blood culture. Collectively, the data collected in this observational cohort study will contribute to further developing sepsis management bundles better suited to settings sub-Saharan Africa.
- Conditions
- Sepsis
- Keywords
- Africa, Tanzania
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with sepsis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis sub-types derived from clinical characteristics.
Number of sepsis subtypes identified by statistical clustering analysis of clinical characteristics.
Measured: Up to 4 years
Sepsis sub-types derived from host immune response to infection.
Number of sepsis subtypes identified by statistical clustering analysis of patient immune response as measured by mRNA gene expression transcrimptomic signature.
Measured: Up to 4 years
Mortality due to sepsis
Time (measured in hours) to fatal event among patients with sepsis as measured by study staff observation or interview.
Measured: Within 28 days of presentation to hospital triage
28-day mortality due to sepsis
Percentage of sepsis patients alive at 28 days after presentation to hospital triage as measured by study staff observation or interview.
Measured: Within 28 days of presentation to hospital triage
Secondary outcomes (9)
Delay in care-seeking for sepsis
Percent of sepsis patients with a World Health Organization severity sign who delayed seeking medical care outside the home > 24 hours after onset of the severity sign as measured by patient/patient representative report.
Measured: Within 24 hours of presentation to hospital triage
Factors that slowed care-seeking
Number of factors that slowed down the decision to seek care at hospital for present illness as measured by patient/patient representative report.
Measured: Within 24 hours of presentation to hospital triage
Time to antibiotics among patients with sepsis
Time in hours from initial presentation at hospital triage to administration of antibiotics among patients with sepsis as measured by study staff observation and hospital records.
Measured: Within 24 hours of presentation to hospital triage
Intravenous venous fluid resuscitation among patients with sepsis
Percentage of sepsis patients who receive intravenous fluids within 6 hours of presentation at hospital triage as measured by study staff observation and real-time review of hospital charting records.
Measured: Within 24 hours of presentation to hospital triage
Volume of intravenous fluid resuscitation among patients with sepsis
Volume (measured in liters) of intravenous fluids received within 6 hours presentation at hospital triage as measured by study staff observation and real-time review of hospital charting records.
Measured: Within 6 hours of presentation to hospital triage
In-hospital mortality due to sepsis
Percentage of sepsis patients who survive to hospital discharge as measured by study staff observation.
Measured: Within 28 days of presentation to hospital triage
7-day mortality due to sepsis
Percentage of sepsis patients alive at 7 days after presentation to hospital triage as measured by study staff observation or interview.
Measured: Within 7 days of presentation to hospital triage
Clinical characteristic sub-type non-classification
Percentage of sepsis patients who could not be classified into a sepsis sub-type derived by statistical clustering of clinical characteristics.
Measured: Up to 4 years
Immune response sub-types non-classification
Percentage of sepsis patients who could not be classified into a sepsis sub-type derived by statistical clustering of patient immune response as measured by mRNA gene expression transcrimptomic signature.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start17 Jan 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Matthew P Rubach, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139459
- Sponsor's protocol ID
- Pro00101917
- Other IDs
- R01AI155733
- Acronym
- SICK
- Status last verified
- Mar 2024
- First submitted
- 11 Nov 2021
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual-level participant data will be de-identified and locator/identifying variables will be removed prior to sharing. Data availability will follow US National Institutes of Health guidelines for genomic data sharing, and it will include uploading annotated gene expression data files to the Gene Expression Omnibus system at the National Center for Biotechnology Information. Any sharing will also comply with regulations of the National Institute for Medical Research in Tanzania, including compliance with data transfer agreements between Kilimanjaro Christian Medical Centre and Duke University.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sepsis in Sub-Saharan Africa: a Prospective Observational Study of Clinical Characteristics, Management, Outcomes, and Barriers to Care in Northern Tanzania
- ClinicalTrials.gov ID
- NCT05139459
- Acronym / sponsor ID
- SICK / Pro00101917
- Conditions
- Sepsis
- Keywords
- Africa, Tanzania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kilimanjaro Christian Medical Centre, Tanzania, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Jan 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 1 Dec 2021 (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.
The aim of this study is to prospectively evaluate the barriers to care, evaluation, clinical practices, and outcomes for patients presenting with sepsis to hospitals in the Kilimanjaro Region of northern Tanzania. This will include an assessment of timing and selection of antimicrobials and administration and volume of intravenous fluids. The study also aims to characterize sepsis sub-types in the epidemiologic context of northern Tanzania using statistical clustering techniques of clinical variables and of host immune response patterns.
Detailed description
A prospective observational cohort study of adolescent and adult patients with sepsis presenting to hospitals in the Kilimanjaro Region, Tanzania. Participants ≥10 years of age with suspected infection and the presence of two of the following will be enrolled: (1) tympanic temperature > 38°C or < 36°C, (2) heart rate > 90 beats/minute, (3) respiratory rate > 20 breaths/minute. Participants will be observed in the Emergency Department and during admission. The following data will be collected: demographics and medical history; history of present illness; laboratory and microbiological workup; antimicrobial selection and timing; intravenous fluid timing and volume. Vital status will be determined at 7 days, hospital discharge, and 28 days post-presentation. An enrollment of up to 1250 patients with sepsis is expected over a two-year period.
This study is expected to produce additional descriptive data of sepsis epidemiology and current practice in sSA. The data will yield important insights regarding key care practices for sepsis, including antimicrobial and intravenous fluid management. Outcomes of patients with sepsis will be described, including an assessment for correlations between current care practices and mortality.
Characterization of potential sepsis sub-types will be undertaken in two domains: 1) clinical characterization via a robust battery of routine clinical laboratories (chemistry, hematology, coagulation studies), vital signs, routine clinical signs and anthropometry; 2) host immune response characterization by analysis of mRNA transcriptome expression in RNA-stabilized whole blood samples. The goal of the sub-type characterization is to identity discrete and clinically relevant sepsis phenotypes, and in doing so eventually help optimize evaluation and management of sepsis specific to the populations and health systems in sub-Saharan Africa. Detailed etiologic investigations will also take place, including blood culture, blood parasite smears, and viral respiratory testing of nasopharyngeal samples; for patients living with HIV, additional evaluations will include serum cryptococcal antigen, urine lipoarabinomannan assay (TB-LAM) and MycoFLytic blood culture. Collectively, the data collected in this observational cohort study will contribute to further developing sepsis management bundles better suited to settings sub-Saharan Africa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with sepsis | – | – |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adolescent and adult patients with sepsis presenting to emergency department or outpatient department at hospitals in Kilimanjaro Region, northern Tanzania.
Key inclusion criteria (4 listed)
- Persons ≥ 10 years of age presenting to hospital suspected to have an infection and meeting two of the following vital signs criteria:
- tympanic >38°C or < 36°C
- a heart rate > 90 beats per minute
- a respiratory rate of > 20 breaths per minute
Key exclusion criteria (4 listed)
- patient with a language barrier
- pregnant female
- a refugee
- a prisoner
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
Sepsis sub-types derived from clinical characteristics.
Time frame: Up to 4 years
Number of sepsis subtypes identified by statistical clustering analysis of clinical characteristics.
Sepsis sub-types derived from host immune response to infection.
Time frame: Up to 4 years
Number of sepsis subtypes identified by statistical clustering analysis of patient immune response as measured by mRNA gene expression transcrimptomic signature.
Mortality due to sepsis
Time frame: Within 28 days of presentation to hospital triage
Time (measured in hours) to fatal event among patients with sepsis as measured by study staff observation or interview.
28-day mortality due to sepsis
Time frame: Within 28 days of presentation to hospital triage
Percentage of sepsis patients alive at 28 days after presentation to hospital triage as measured by study staff observation or interview.
9 secondary outcomes
Delay in care-seeking for sepsis
Time frame: Within 24 hours of presentation to hospital triage
Factors that slowed care-seeking
Time frame: Within 24 hours of presentation to hospital triage
Time to antibiotics among patients with sepsis
Time frame: Within 24 hours of presentation to hospital triage
Intravenous venous fluid resuscitation among patients with sepsis
Time frame: Within 24 hours of presentation to hospital triage
Volume of intravenous fluid resuscitation among patients with sepsis
Time frame: Within 6 hours of presentation to hospital triage
In-hospital mortality due to sepsis
Time frame: Within 28 days of presentation to hospital triage
7-day mortality due to sepsis
Time frame: Within 7 days of presentation to hospital triage
Clinical characteristic sub-type non-classification
Time frame: Up to 4 years
Immune response sub-types non-classification
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes. Individual-level participant data will be de-identified and locator/identifying variables will be removed prior to sharing. Data availability will follow US National Institutes of Health guidelines for genomic data sharing, and it will include uploading annotated gene expression data files to the Gene Expression Omnibus system at the National Center for Biotechnology Information. Any sharing will also comply with regulations of the National Institute for Medical Research in Tanzania, including compliance with data transfer agreements between Kilimanjaro Christian Medical Centre and Duke University.
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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.
Matthew P Rubach, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Duke University at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sepsis sub-types derived from clinical characteristics. (time frame: Up to 4 years). The study lists 4 primary outcomes in all. 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 21 Mar 2024.