NCT07174648

Brief Summary

This study is being done to learn more about the disease in Ituri and to evaluate a new rapid test that may help doctors find the disease more quickly. This research includes characterisation of clinical presentations and pathology of plague, as well as identification of circumstances that may increase the risk of infection. Biological samples collected include blood, mouth swab, saliva, a bubo aspirate and a sputum sample (the latter only in case of plague in the lungs). These samples will be used to test the performance of the new rapid study test.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started May 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

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%
May 2026Jan 2029

First Submitted

Initial submission to the registry

September 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 16, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2029

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

2.7 years

First QC Date

September 8, 2025

Last Update Submit

March 24, 2026

Conditions

PlagueBubonic; Plague, SkinPlague, Pneumonic

Keywords

PlagueBubonic PlaguePneumonic PlagueIturiDRCAntigen rapid diagnostic test

Outcome Measures

Primary Outcomes (1)

  • Duplex F1V RDT performance

    Sensitivity, specificity, positive and negative predictive value of the Duplex F1V RDT results on different biological fluids, i.e. (1) gingival sulcus fluid, (2) saliva, (3) venous blood, (4) bubo aspirates and/or (5) sputum (depending on clinical presentation), as compared to positive PCR

    3 years

Secondary Outcomes (5)

  • Agreement between Duplex F1V RDT results in each biological fluid and PCR results on the same fluid

    3 years

  • Profile (type, frequency, severity) of clinical features observed among PCR-confirmed plague cases at presentation and during follow-up until treatment completion

    3 years

  • Epidemiological and clinical factors (with their respective odd ratios) associated with PCR-confirmed infection, compared to PCR-negative suspects (nested test negative design)

    3 years

  • Proportion of PCR confirmed cases with recovery, death or lost to follow-up assessed at the end of treatment

    3 years

  • Sensitivity and specificity of the current national clinical case definition for the DRC Ituri focus, and investigation of alternative optimized clinical combinations for plague suspicion

    3 years

Study Arms (1)

Group 1

Cross-sectional Nested test-negative case-control study

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People (\> 5 years of age), living within Rethy, Logo and Aru health zones

You may qualify if:

  • All participants (aged ≥5 year old) within Rethy, Logo and Aru health zones, presenting with possible symptoms of bubonic and/or pneumonic plague according to WHO definition
  • Willing to provide voluntary consent (or voluntary assent and parental consent in case of minors.

You may not qualify if:

  • Participants not eligible, able, or willing to undergo study procedures
  • Children \<5 years of age
  • Participants on antibiotic treatment ≥48h prior to recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre De Recherche en Maladies Tropicales De L'ituri

Rethy, Democratic Republic of the Congo

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bubonic Aspirate, Sputum, Saliva, Gingival sulcus swabs, venous blood

MeSH Terms

Conditions

Plague

Condition Hierarchy (Ancestors)

Yersinia InfectionsEnterobacteriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsVector Borne Diseases

Study Officials

  • Laurens Liesenborghs

    Institute of Tropical Medicine, Antwerp, Belgium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elise De Vos

CONTACT

+3233455672edevos@itg.be

Study Design

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

Study Record Dates

First Submitted

September 8, 2025

First Posted

September 16, 2025

Study Start

May 1, 2026

Primary Completion (Estimated)

January 2, 2029

Study Completion (Estimated)

January 2, 2029

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

DE(1)