Rapid molecular testing to find infections in travelers with tropical fever
Rapid Molecular Diagnosis and Detection of Emerging Infectious Diseases in Patients With Tropical Fever
This project will see if rapid molecular tests can quickly identify infections in adults who come to the emergency department with fever after returning from tropical countries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 564 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06539325 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults presenting to an emergency department in Paris with fever (≥38°C) within 28 days of return from tropical regions, excluding patients with sepsis or those requiring hospitalization. Participants follow a diagnostic algorithm that uses rapid molecular (syndromic) testing timed to the delay since travel to detect respiratory viruses, arboviruses and other emerging pathogens. The study compares the molecular-based syndromic approach with usual diagnostic pathways to measure diagnostic yield, time to pathogen identification, and downstream effects on treatment, monitoring and follow-up. It also aims to strengthen detection of new or re-emerging infectious threats to improve public-health response.
Who should consider this trial
Good fit: Adults (≥18 years) with a measured fever (≥38°C) presenting to the ED within 28 days of return from tropical regions who do not have sepsis, do not require hospitalization, and can consent are eligible.
Not a fit: Patients who are already hospitalized, have sepsis or high acuity, are unable to give consent, or whose fever began more than 28 days after travel are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could produce faster, more accurate diagnoses so patients get appropriate treatment sooner and public-health teams can detect outbreaks earlier.
How similar studies have performed: Syndromic rapid molecular testing has shown promise in ICU and respiratory settings, but its routine use for non-severe returning travelers in emergency departments is novel and not well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris, Paris
- Service des Urgences — Paris, Paris, France (Recruiting)
Study contacts
- Study coordinator: Nathan PEIFFER-SMADJA, MD, PhD
- Email: nathan.peiffer-smadja@aphp.fr
- Phone: 01 40 25 73 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.