Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Plague, Bubonic; Plague, Skin, Plague, Pneumonic. Basic parameters: from 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Democratic Republic of the Congo
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR Congo
Overview
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.
Detailed description
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.
Primary outcome measures
- Duplex F1V RDT performance [Time frame: 3 years]
Secondary outcome measures (5)
- Agreement between Duplex F1V RDT results in each biological fluid and PCR results on the same fluid [Time frame: 3 years]
- 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]
- 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]
- Proportion of PCR confirmed cases with recovery, death or lost to follow-up assessed at the end of treatment [Time frame: 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 [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Democratic Republic of the Congo · 1 center
- Centre De Recherche en Maladies Tropicales De L'ituri — Rethy
Identifiers
NCT: NCT07174648 · RAPID-IT