NCT06539325 Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever (Tropifever)
| NCT ID | NCT06539325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Infectious Diseases in Febrile Patients Returning From Tropical Countries |
| Study Type | INTERVENTIONAL |
| Enrollment | 564 participants |
| Start Date | 2024-08-26 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 564 participants in total. It began in 2024-08-26 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06539325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Infectious Diseases in Febrile Patients Returning From Tropical Countries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06539325 currently recruiting?
Yes, NCT06539325 is actively recruiting participants. Contact the research team at nathan.peiffer-smadja@aphp.fr for enrollment information.
Where is the NCT06539325 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06539325 clinical trial?
NCT06539325 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 564 participants.