Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever (Tropifever)
NCT Number: NCT06539325
Acronym: Tropifever
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Infectious Diseases in Febrile Patients Returning From Tropical Countries
Interventions: DIAGNOSTIC_TEST: Diagnosis algorithm according to the delay between travel and consultation
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 564
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08-01
Completion Date: 2026-12-01

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.

Primary Outcome Measures: Number of Patient informed of a microbiologically confirmed infection and of the appropriate course of action within five days after the initial visit to the emergency department., Number of Patient informed of a microbiologically confirmed infection and of the appropriate course of action within five days after the initial visit to the emergency department., 5 days
Secondary Outcome Measures: Number of Patient with a microbiologically confirmed diagnosis within 5 days after ED visit., Number of Patient with a microbiologically confirmed diagnosis within 5 days after ED visit., 5days|Number of Lost to follow up patient: a patient will be considered lost to follow up if no contact has been established to informed him of the result of the diagnostic tests within 5 days after ED visit (neither by phone nor during a hospital visit)., Number of Lost to follow up patient: a patient will be considered lost to follow up if no contact has been established to informed him of the result of the diagnostic tests within 5 days after ED visit (neither by phone nor during a hospital visit)., 3 months|Number of Hospitalizations linked to the diagnosis, according to the physician in charge, in the 3 months following inclusion, Number of Hospitalizations linked to the diagnosis, according to the physician in charge, in the 3 months following inclusion, 3 months|Mortality at 3 months following ED visit, mortality linked to the diagnosis according to the investigator or the physician in charge of the patient at 3 months following ED visit, Mortality at 3 months following ED visit, mortality linked to the diagnosis according to the investigator or the physician in charge of the patient at 3 months following ED visit, 3 months|Number of the specific management of patients, including:

* Additional investigations
* Systematic monitoring (e.g., thrombocytopenia in case of dengue fever)
* Dedicated long-term follow-up (e.g., HIV follow-up)
* Antimicrobial treatments
* Isolation measures
* Family screening
* Public health measures such as mandatory reporting (signalling and notification), 3 months|Total Cost of the strategy of infectious disease management, Total Cost of the strategy of infectious disease management, 3 months|Diagnostic performances of the Dragonfly panel compared to reference PCR panel: sensitivity, specificity, positive and negative predictive values will be calculated, Diagnostic performances of the Dragonfly panel compared to reference PCR panel: sensitivity, specificity, positive and negative predictive values will be calculated, 3 months|Delay (number of days) in the addition of a new set of primers in the Dragonfly panel, In the case of the emergence of a new respiratory pathogen, such as SARS-CoV-2 in 2019, additional secondary endpoints will be added, 3 months|Diagnostic performance of the new set of primers integrated into the Dragonfly panel compared to the PCR developed by the French and international reference centers (sensitivity, specificity, positive predictive value, negative predictive value), In the case of the emergence of a new respiratory pathogen, such as SARS-CoV-2 in 2019, additional secondary endpoints will be added, 3 months|Length of hospitalizations linked to the diagnosis, according to the physician in charge, in the 3 months following inclusion, Length of hospitalizations linked to the diagnosis, according to the physician in charge, in the 3 months following inclusion, 3 months|Total cost of compliance with the diagnostic workup, Total cost of compliance with the diagnostic workup, 3 months|Number of hospitalizations and linked mortality at 3months, Number of hospitalizations and linked mortality, 3 months|Number of death at 3 months, Number of death at 3 months, 3 months