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RecruitingNCT07711535Updated Sep 9, 2026

Development of Context-Adapted Quality Indicators for Early Sepsis Care in Sub-Saharan Africa - A Modified Delphi Consensus Procedure

An observational study in Sepsis, sponsored by Charite University, Berlin, Germany. Recruiting at 1 site in Ghana. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Charite University, Berlin, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
45
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

The expert panel will be recruited through purposive sampling via existing national and international sepsis networks (including the Sub-Saharan African Consortium for the Advancement of Innovative Research and Care in Africa, "STAIRS"), scientific collaborations, and personal invitations from the study team in Berlin.

Invited are professionals with proven experience in sepsis care or sepsis research in sub-Saharan Africa, including physicians, nurses, researchers, and other healthcare professionals involved in acute care and quality assurance.

For the first Delphi round, the investigators plan to recruit approximately 10-15 experts. In a second recruitment phase, participants may nominate additional experts with relevant expertise (snowball sampling). The total number of panel members should not exceed 30-45.

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Conditions studied

  • Sepsis

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03

In context

Sepsis

2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.

This study's planned enrollment of 45 is below the median of 150 across 1,162 observational studies indexed under Sepsis.

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Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 857 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
45 participants (estimated)
Patient registry
No
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What researchers measure

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) .

    Time frame: Up to October 2026

Secondary outcomes

  1. The final, agreed-upon set of quality indicators

    The final, agreed-upon set of quality indicators is developed during the project

    Time frame: Up to October 2026

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

    The agreed-upon structure of the STEPS survey instrument.

    Time frame: Up to October 2026

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

    The agreed-upon content of the STEPS survey instrument.

    Time frame: Up to October 2026

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07711535
Responsible party
Claudia Spies (Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charite University, Berlin, Germany) — Principal investigator
First posted
Jul 17, 2026
Start date
Sep 2026 (estimated)
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 9, 2026

Study contacts

Claudia Spies, MD, Prof.
Contact
claudia.spies@charite.de
+49 30 450 55 11 02
Claudia Spies, MD, Prof.
study director · Charite University, Berlin, Germany

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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