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NCT Number: NCT07174648

Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.

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.

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Key information

Conditions

Plague Bacterial Infections Bacterial Infections and Mycoses Bubonic; Plague, Skin Enterobacteriaceae Infections Gram-Negative Bacterial Infections Infections Plague, Pneumonic Vector Borne Diseases Yersinia Infections

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre De Recherche en Maladies Tropicales De L'ituri

Rethy, Democratic Republic of the Congo

Location contact

Pascal Adroba Tandele

CONTACT

[email protected]

Pascal Adroba Tandele

PRINCIPAL_INVESTIGATOR

About this study

Plague is a life-threatening infection caused by the bacterium Yersinia pestis, which is highly endemic in the Ituri Province of the Democratic Republic of Congo (DRC) and associated with recurrent risks of regional epidemic spread. Clinical presentations (bubonic and/or pulmonary) and outcome remain poorly characterised in this area, and diagnostic accuracy is limited due to absence of a local bacteriology laboratory.

A novel lateral-flow immunochromatographic duplex rapid diagnostic test (RDT) has been developed for plague, which detects both F1 and LcrV proteins, and appears superior to the current RDT detecting only F1 antigens. This index RDT (called Duplex F1V) has shown promise in detecting Yersinia pestis in various sample types, including blood, bubo aspirates, and saliva in human patients.

Cross-sectional diagnostic accuracy study in clinical suspects of plague, comparing the results of Duplex F1V RDT (index assay), with PCR (polymerase chain reaction) positivity (as reference assay) on different biological fluids and assessment of clinical outcome at the end of treatment (at day 10-14).

Nested test-negative case-control study to identify risk factors and clinical predictors in PCR-confirmed plague cases, compared to PCR-negative suspects.

The study will take place in the Ituri province of DRC, the world's largest plague focus. Participants will be recruited in health centers and reference hospitals in the health areas of Rethy, Logo and Aru where the teams of the "Centre de Recherche en Maladies Tropicales" (CRMT) of Ituri are active. Individuals ≥5 years of age presenting at the sites with clinical suspicion of plague -as per national clinical case definitions- will be enrolled after informed consent and followed-up until treatment completion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Duplex F1V RDT performance

    Time frame: 3 years

    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

Secondary outcomes

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

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

    Time frame: 3 years

  5. 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

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Elise De Vos

CONTACT

[email protected]

+3233455672

Sponsors and collaborators

Lead sponsor

Institute of Tropical Medicine, Belgium

Other

Collaborators

  • Centre de Recherche en Maladies Tropicales de L'Ituri (CRMT)
  • Institut National pour la Recherche Biomedicale (INRB)
  • Institut Pasteur
  • Université Paris-Saclay

Registry information

Official study title

Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR Congo

Acronym: RAPID-IT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 16, 2025
Registry last updated
Mar 27, 2026

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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