Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT06539325

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-06

564

Participants Needed

1

Research Sites

118 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (age  18 years old)
  • Fever with tympanic temperature above 38 0C measured in the emergency department
  • Returned from tropical countries (Sub-Saharan Africa, South and Southeast Asia, Central and South America) within 28 days
  • No sepsis with quick SOFA score less than 2
Not Eligible

You will not qualify if you...

  • Patient requiring hospitalization
  • Unable to consent due to unconsciousness or language barrier without translator
  • Under legal protection measures such as guardianship, curatorship, legal protection, deprivation of liberty, or psychiatric hospitalization
  • Patient refusing to participate

AI-Screening

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Trial Site Locations

Total: 1 location

1

Service des Urgences

Paris, Paris, France, 75018

Actively Recruiting

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Research Team

N

Nathan PEIFFER-SMADJA, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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