Sepsis Characterization in Kilimanjaro

NCT05139459 | Completed

• 2 other identifiers: Pro00101917R01AI155733
• Study Type: observational
• Target: 499
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sepsis

Keywords

Africa; Tanzania

Outcome Measures

Primary Outcomes (4)

• Sepsis sub-types derived from clinical characteristics.

  Number of sepsis subtypes identified by statistical clustering analysis of clinical characteristics.

  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.

  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.

  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.

  Within 28 days of presentation to hospital triage

Secondary Outcomes (9)

• Delay in care-seeking for sepsis

  Within 24 hours of presentation to hospital triage

• Factors that slowed care-seeking

  Within 24 hours of presentation to hospital triage

• Time to antibiotics among patients with sepsis

  Within 24 hours of presentation to hospital triage

• Intravenous venous fluid resuscitation among patients with sepsis

  Within 24 hours of presentation to hospital triage

• Volume of intravenous fluid resuscitation among patients with sepsis

  Within 6 hours of presentation to hospital triage

Other Outcomes (10)

• Sepsis due to respiratory syndrome

  Within 24 hours of presentation to hospital triage

• Sepsis due to neurologic syndrome

  Within 24 hours of presentation to hospital triage

• Sepsis due to genito-urinary syndrome

  Within 24 hours of presentation to hospital triage

Study Arms (1)

Participants with sepsis

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent and adult patients with sepsis presenting to emergency department or outpatient department at hospitals in Kilimanjaro Region, northern Tanzania.

You may qualify if:

• 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

You may not qualify if:

• patient with a language barrier
• pregnant female
• a refugee
• a prisoner

Sponsors & Collaborators

• Duke University: lead
• Kilimanjaro Christian Medical Centre, Tanzania: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Duke University Medical Centre

Durham, North Carolina, 27706, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be collected in a PaxGene RNA stabilizing tube (BD, Franklin Lakes, New Jersey, USA) at 4 time-points and archived for future studies regarding causes of sepsis or measuring the dysregulated immune response in sepsis, specifically to investigate biomarkers for sepsis mortality and biomarkers to improve triage for sepsis patients in resource-limited settings. These archived samples may also be utilized for etiologic investigations for causes of sepsis using tests for nucleic acid detection or serologic assays. Additional specimen archival (at -80 C) will include the following sample types: Nasopharyngeal specimens in universal transport media will be archived for future respiratory pathogen testing. EDTA-whole blood, EDTA-derived plasma, sodium citrate-derived plasma, dried blood spots, serum, and blood culture broths will be archived for future etiologic or immunologic investigations.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthew P Rubach, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2021
• First Posted: December 1, 2021
• Study Start: January 17, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Gene expression data will become available at time of submission of the first manuscript that describes any such data. Additional data will be available per publisher or US National Institutes of Health policies or by written request to the Principal Investigators, provided that the sharing is compliant with the data sharing policies of the Tanzanian National Institute for Medical Research. Once available, there are no anticipated restrictions on the duration of availability.
• Access Criteria: For data uploaded to the Gene Expression Omnibus, access will be designated per the policies of the US National Center for Biotechnology Information. For data uploaded in compliance with publishers, access will be designated per the policies of the publisher. Data can also be shared upon written request to the Principal Investigators and only shared once appropriate data sharing procedures have taken place in accordance with the policies of the Tanzanian National Institute for Medical Research.

Locations

US (1)