Health Trials

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

ConditionsPlagueBubonic; Plague, SkinPlague, Pneumonic
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorInstitute of Tropical Medicine, Belgium

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Participants not eligible, able, or willing to undergo study procedures

Children <5 years of age

Participants on antibiotic treatment ≥48h prior to recruitment

Trial population

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

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 1 trial group
Group A: Group 1

Trial outcomes

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

Time frame
3 years

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Tropical Medicine, Belgium

Lead sponsor

Institut Pasteur

Collaborator

Université Paris-Saclay

Collaborator

Centre de Recherche en Maladies Tropicales de L'Ituri (CRMT)

Collaborator

Institut National pour la Recherche Biomedicale (INRB)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: