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Completed

NCT Number: NCT05139459

Sepsis Characterization in Kilimanjaro

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

10 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Centre

Durham, North Carolina, 27706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. Factors that slowed care-seeking

    Time frame: Within 24 hours of presentation to hospital triage

    Number of factors that slowed down the decision to seek care at hospital for present illness as measured by patient/patient representative report.

  3. Time to antibiotics among patients with sepsis

    Time frame: Within 24 hours of presentation to hospital triage

    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.

  4. 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.

  5. Volume of intravenous fluid resuscitation among patients with sepsis

    Time frame: Within 6 hours of presentation to hospital triage

    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.

  6. In-hospital mortality due to sepsis

    Time frame: Within 28 days of presentation to hospital triage

    Percentage of sepsis patients who survive to hospital discharge as measured by study staff observation.

  7. 7-day mortality due to sepsis

    Time frame: Within 7 days of presentation to hospital triage

    Percentage of sepsis patients alive at 7 days after presentation to hospital triage as measured by study staff observation or interview.

  8. Clinical characteristic sub-type 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 clinical characteristics.

  9. 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.

Other outcomes

  1. Sepsis due to respiratory syndrome

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with a respiratory syndrome as measured by study staff standardized observation of signs and symptoms.

  2. Sepsis due to neurologic syndrome

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with a neurologic syndrome as measured by study staff standardized observation of signs and symptoms.

  3. Sepsis due to genito-urinary syndrome

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with a geninto-urinary syndrome as measured by study staff standardized observation of signs and symptoms.

  4. Sepsis due to skin/soft tissue syndrome.

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with a skin/soft tissue syndrome as measured by study staff standardized observation of signs and symptoms.

  5. Sepsis due to gastrointestinal syndrome.

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with a gastrointestinal syndrome as measured by study staff standardized observation of signs and symptoms.

  6. Sepsis due to undifferentiated syndrome.

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients presenting with an undifferentiated syndrome as measured by study staff standardized observation of signs and symptoms.

  7. HIV-infection among sepsis patients

    Time frame: Within 24 hours of presentation to hospital triage

    Percentage of sepsis patients who are infected with HIV as measured by World Health Organization approved rapid HIV antibody testing.

  8. Sepsis severity of illness

    Time frame: Within 24 hours of presentation to hospital triage

    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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Kilimanjaro Christian Medical Centre, Tanzania
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Sepsis in Sub-Saharan Africa: a Prospective Observational Study of Clinical Characteristics, Management, Outcomes, and Barriers to Care in Northern Tanzania

Acronym: SICK

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2021
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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