RecruitingNot ApplicableNCT06539325

Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever (Tropifever)

Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

564 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Travellers returning from tropical countries often present to emergency departments with acute fever. While systematic screening for malaria is well established in clinical practice in France, further diagnostic testing for infectious diseases is less codified. In addition, the clinical presentation of many tropical and emerging infectious diseases is often similar, making a positive diagnosis in these patients challenging. Improving the microbiological diagnostic strategy for febrile travellers is crucial because the lack of an accurate diagnosis in many of these patients prevents the implementation of appropriate diagnostic and therapeutic measures. These measures include antimicrobial treatment, but also additional investigations, specialised monitoring and the initiation of follow-up of acute or chronic infections. In addition, the current diagnostic approach to tropical fevers is poorly suited to detect outbreaks associated with a new or re-emerging infectious disease and to alert public health authorities in a timely manner. Therefore, this project aims to evaluate the impact of a systematic and expanded microbiological diagnostic strategy for patients presenting to the emergency department with fever after returning from tropical countries. To evaluate this testing strategy, the investigators propose to conduct a multicentre, cluster-randomised, cross-over trial comparing standard care with a systematic microbiological diagnostic algorithm added to standard care.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • Adult (age ≥ 18 years old)
  • Fever (tympanic temperature above 38°c measured in the emergency department)
  • Within 28 days of returning from tropical countries (Sub-Saharan Africa, South and Southeast Asia, Central and South America)
  • No sepsis (qSOFA < 2)

Exclusion Criteria4

  • Patient requiring hospitalization
  • Patient unable to consent: unconscious or language barrier without an available translator
  • Patient under legal protection measure (guardianship, curatorship, legal protection, deprivation of liberty, hospitalisation for psychiatric care)
  • Patient refusing to participate

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Interventions

DIAGNOSTIC_TESTDiagnosis algorithm according to the delay between travel and consultation

Tests : RT-PCR for the most common arboviruses (Dengue, Zika, Chikungunya, and West Nile virus) and serology for dengue infection (NS1 antigen, and IgM and IgG), serologies for chronic viral infections (HIV, HBV and HCV) and schistosomiasis, Blood cultures and Innovativ Diagnostics : panel Dragonfly and two metagenomic analyses


Locations(1)

Service des Urgences

Paris, Paris, France

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NCT06539325