- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05139459
Sepsis Characterization in Kilimanjaro (SICK)
Sepsis in Sub-Saharan Africa: a Prospective Observational Study of Clinical Characteristics, Management, Outcomes, and Barriers to Care in Northern Tanzania
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Matthew P Rubach, MD
- Phone Number: 919-684-2660
- Email: matthew.rubach@duke.edu
Study Contact Backup
- Name: Timothy Veldman, PhD
- Phone Number: 919-684-3835
- Email: tim.veldman@duke.edu
Study Locations
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North Carolina
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Durham, North Carolina, United States, 27706
- Duke University Medical Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
- patient with a language barrier
- pregnant female
- a refugee
- a prisoner
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Participants with sepsis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Up to 4 years
|
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.
|
Up to 4 years
|
Mortality due to sepsis
Time Frame: Within 28 days of presentation to hospital triage
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Time (measured in hours) to fatal event among patients with sepsis as measured by study staff observation or interview.
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Within 28 days of presentation to hospital triage
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28-day mortality due to sepsis
Time Frame: Within 28 days of presentation to hospital triage
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Percentage of sepsis patients alive at 28 days after presentation to hospital triage as measured by study staff observation or interview.
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Within 28 days of presentation to hospital triage
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delay in care-seeking for sepsis
Time Frame: Within 24 hours of presentation to hospital triage
|
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.
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Within 24 hours of presentation to hospital triage
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Factors that slowed care-seeking
Time Frame: Within 24 hours of presentation to hospital triage
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Number of factors that slowed down the decision to seek care at hospital for present illness as measured by patient/patient representative report.
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Within 24 hours of presentation to hospital triage
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Time to antibiotics among patients with sepsis
Time Frame: Within 24 hours of presentation to hospital triage
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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.
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Within 24 hours of presentation to hospital triage
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Intravenous venous fluid resuscitation among patients with sepsis
Time Frame: Within 24 hours of presentation to hospital triage
|
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.
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Within 24 hours of presentation to hospital triage
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Volume of intravenous fluid resuscitation among patients with sepsis
Time Frame: Within 6 hours of presentation to hospital triage
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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.
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Within 6 hours of presentation to hospital triage
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In-hospital mortality due to sepsis
Time Frame: Within 28 days of presentation to hospital triage
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Percentage of sepsis patients who survive to hospital discharge as measured by study staff observation.
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Within 28 days of presentation to hospital triage
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7-day mortality due to sepsis
Time Frame: Within 7 days of presentation to hospital triage
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Percentage of sepsis patients alive at 7 days after presentation to hospital triage as measured by study staff observation or interview.
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Within 7 days of presentation to hospital triage
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Clinical characteristic sub-type non-classification
Time Frame: Up to 4 years
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Percentage of sepsis patients who could not be classified into a sepsis sub-type derived by statistical clustering of clinical characteristics.
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Up to 4 years
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Immune response sub-types non-classification
Time Frame: Up to 4 years
|
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.
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Up to 4 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sepsis due to respiratory syndrome
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a respiratory syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
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Sepsis due to neurologic syndrome
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a neurologic syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
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Sepsis due to genito-urinary syndrome
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a geninto-urinary syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
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Sepsis due to skin/soft tissue syndrome.
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a skin/soft tissue syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
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Sepsis due to gastrointestinal syndrome.
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a gastrointestinal syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
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Sepsis due to undifferentiated syndrome.
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with an undifferentiated syndrome as measured by study staff standardized observation of signs and symptoms.
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Within 24 hours of presentation to hospital triage
|
HIV-infection among sepsis patients
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients who are infected with HIV as measured by World Health Organization approved rapid HIV antibody testing.
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Within 24 hours of presentation to hospital triage
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Sepsis severity of illness
Time Frame: Within 24 hours of presentation to hospital triage
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Percentage of sepsis patients presenting with a Universal Vital Assessment score > 4 as measured by study staff standardized observation of vital signs and measurement of HIV infection status.
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Within 24 hours of presentation to hospital triage
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Pre-specified sub-group analysis: enrolled participants with Sequential Organ Failure Assessment (SOFA) score of 2 or greater.
Time Frame: Up to 4 years
|
The above outcomes will also be examined for this pre-specified sub-group of enrolled participants-- those who have a SOFA score of 2 or greater at the time of screening and enrollment.
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Up to 4 years
|
Pre-specified sub-group analysis: enrolled participants with C-reactive protein measurement of 15 mg/L or higher
Time Frame: Up to 4 years
|
The above outcomes will also be examined for this pre-specified sub-group of enrolled participants-- those who have a C-reactive protein serum measurement of above 15 mg/L (above the upper limit of a normal reference range in East Africa) at the time of screening and enrollment.
|
Up to 4 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew P Rubach, MD, Duke University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00101917
- R01AI155733 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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