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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Service des Urgences
RECRUITING
Paris
Contact Information
Primary
Nathan PEIFFER-SMADJA, MD, PhD
nathan.peiffer-smadja@aphp.fr
01 40 25 73 11
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 564
Treatments
Experimental: Intervention period
Patient management will be guided by a systematic microbiological diagnostic strategy
No_intervention: Control period
Patient management will be done according to the usual practices of centers and emergency physicians
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov