PlagueRAPID-ITNCT07174648
Testing of a New Rapid Antigen Test for Plague in Ituri, Democratic Republic of the Congo.
An observational study of Plague and Bubonic; Plague, Skin, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Plague, Bubonic; Plague, Skin, Plague, Pneumonic
- How many people
- 300 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- 1 Dec 2026to 2 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People (> 5 years of age), living within Rethy, Logo and Aru health zones
Who may be able to join
- 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.
Who cannot join
- Participants not eligible, able, or willing to undergo study procedures
- Children <5 years of age
- Participants on antibiotic treatment ≥48h prior to recruitment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Democratic Republic of the Congo1 site
Centre De Recherche en Maladies Tropicales De L'ituri
Rethy
Pascal Adroba Tandele, pascaladroba2017@gmail.com
Pascal Adroba Tandele
About this study
Official title: Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR 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.
Read the 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.
- Conditions
- Plague, Bubonic; Plague, Skin, Plague, Pneumonic
- Keywords
- Plague, Bubonic Plague, Pneumonic Plague, Ituri, DRC, Antigen rapid diagnostic test
- Medical subject headings
- Plague
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Cross-sectional Nested test-negative case-control study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (5)
Agreement between Duplex F1V RDT results in each biological fluid and PCR results on the same fluid
Measured: 3 years
Profile (type, frequency, severity) of clinical features observed among PCR-confirmed plague cases at presentation and during follow-up until treatment completion
Measured: 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)
Measured: 3 years
Proportion of PCR confirmed cases with recovery, death or lost to follow-up assessed at the end of treatment
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Dec 2026 (estimated)
- Primary completion2 Jan 2029 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlagueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Université Paris-Saclay, Centre de Recherche en Maladies Tropicales de L'Ituri (CRMT), Institut National pour la Recherche Biomedicale (INRB)
- Responsible party
- Sponsor
- Investigators
- Laurens Liesenborghs, Principal investigator, Institute of Tropical Medicine, Antwerp, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174648
- Sponsor's protocol ID
- RAPID-IT
- Acronym
- RAPID-IT
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Only anonymized individual participant data may be shared. Details are still under discussion with the relevant partners
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Evaluation of a Novel Antigen Rapid Diagnostic Test for Plague in the Province of Ituri, DR Congo
- ClinicalTrials.gov ID
- NCT07174648
- Acronym / sponsor ID
- RAPID-IT / RAPID-IT
- Conditions
- Plague, Bubonic; Plague, Skin, Plague, Pneumonic
- Keywords
- Plague, Bubonic Plague, Pneumonic Plague, Ituri, DRC, Antigen rapid diagnostic test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Institut Pasteur, Université Paris-Saclay, Centre de Recherche en Maladies Tropicales de L'Ituri (CRMT), Institut National pour la Recherche Biomedicale (INRB)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 2 Jan 2029 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Cross-sectional Nested test-negative case-control study |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People (> 5 years of age), living within Rethy, Logo and Aru health zones
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Participants not eligible, able, or willing to undergo study procedures
- Children <5 years of age
- Participants on antibiotic treatment ≥48h prior to recruitment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: Undecided. Only anonymized individual participant data may be shared. Details are still under discussion with the relevant partners
Related trials for Plague
Active, not recruitingPhase 2
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Recruiting
Modifying PEST for Psoriatic Arthritis Screening
Plaque Psoriasis, Psoriatic Arthritis
Active, not recruitingPhase 1
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Recruiting
The Dental Care Revolution: Health Education Using AI or Humanized Counseling on Plague Control and Periodontal Treatment Outcome in Patients With Periodontal Disease
Periodontal Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurens Liesenborghs principal investigator
Institute of Tropical Medicine, Antwerp, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plague and Bubonic; Plague, Skin, run by Institute of Tropical Medicine, Belgium at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elise De Vos (+3233455672, edevos@itg.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duplex F1V RDT performance (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.