NCT07711535

Brief Summary

The research project is an anonymous, prospective, non-interventional consensus study in the form of a modified Delphi method, consisting of three online surveys and structured feedback meetings without recording. The goal is the structured evaluation and consolidation of expert assessments to develop context-adapted quality indicators and operationalize them for early sepsis care in sub-Saharan Africa.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Oct 2026

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • The degree of expert consensus on individual quality indicators

    The degree of expert consensus on individual quality indicators, measured on a 5-point Likert scale (median and interquartile range) .

    Up to October 2026

Secondary Outcomes (3)

  • The final, agreed-upon set of quality indicators

    Up to October 2026

  • The agreed-upon structure of the STEPS survey instrument.

    Up to October 2026

  • The agreed-upon content of the STEPS survey instrument.

    Up to October 2026

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa, including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance.

You may qualify if:

  • Professionals with proven experience in sepsis care or sepsis research in low- and middle-income countries, particularly Sub-Saharan Africa including physicians, nurses, researchers, and other healthcare professionals involved in early acute care and quality assurance
  • Minimum age of 18
  • Willingness to voluntarily participate in one or more Delphi rounds

You may not qualify if:

  • Lack of professional expertise in the field of sepsis care
  • Refusal to consent to participation
  • Withdrawal from participation at the participant's own request

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudia Spies, MD, Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Central Study Contacts

Claudia Spies, MD, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share