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

NCT06539325 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2025-06-06

No results posted yet for this study

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.

Conditions

  • Infectious Diseases in Febrile Patients Returning From Tropical Countries

Interventions

DIAGNOSTIC_TEST

Diagnosis 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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2026-11-01
Completion
2026-12-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06539325 on ClinicalTrials.gov