Last reviewed · How we verify
NCT03784248: AsymptoGen
Mediterranean Visceral Leishmaniasis With Leishmania Infantum
trial testing blood donation and isolation of leuco-platelet layers in Leishmaniasis in 1,400 participants. Participants enrolled and being followed up; not accepting new ones.
15 July 2025
Quick facts
| Lead sponsor | Centre Hospitalier Universitaire de Nice |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 1,400 |
| Start date | 3 July 2019 |
| Primary completion | 15 July 2025 |
| Estimated completion | 15 August 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- blood donation and isolation of leuco-platelet layers
Conditions studied
- Leishmaniasis — all drugs for Leishmaniasis →
Sponsor
Centre Hospitalier Universitaire de Nice
Who can join
Adults 18 to 70, any sex, with Leishmaniasis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
L. infantum leishmaniasis is endemic in the South of France. For several years, there has been an expansion of the territory of sandflies (vector of leishmaniasis), with the appearance of cases of canine leishmaniasis in new outbreaks: West of the Occitania region (South-West). The transition from asymptomatic to disease depends largely on the immune status of the carrier, but many other factors specific to the parasite and host remain poorly defined. Asymptomatic carriage is present in a large majority of infected subjects, however, to date, only parasite isolates causing the patent form have been characterized. In this PHRC, the team wishes to study the genetics of parasite isolates present in asymptomatic carriers of the Alpes-Maritimes outbreak and the new Occitanie outbreak as well as the genetics of the host. The primary objective is the genetic characterization of L. infantum isolates by the microsatellite method, present in asymptomatic carriers in southeast and southwestern France. The secondary objectives are: 1. Comparison of the genetic profiles of L. infantum isolates, by microsatellite method, from asymptomatic carriers of the new Southwestern outbreak with isolates from asymptomatic carriers of the historical Southwestern outbreak. 2. Comparison of the genetic profiles of L. infantum isolates, by the microsatellite method, present in asymptomatic carriers in the Southeast with the profiles of isolates present in patients in the same outbreak, for whom a microsatellite study has already been obtained previously. 3. the team is also conducting a preliminary study of the host genetic factors that would be associated with asymptomatic carriage by studying the association between potential host-related genetic risk factors (HLA typing, NLRP3 gene study) and asymptomatic carriage. Indeed, a recent study showed that the NLRP3 gene prevents the development of the patent form of leishmaniasis in the mouse model. This preliminary genetic study will identify potential host-related factors associated with asymptomatic carriage. To meet these objectives, leuco-platelet layer parasites (CLP) obtained via EFS from the 2 sources of interest will be isolated. This project is a research not involving the human person. It is multicentric and non-randomized. As a result of this research, isolates from asymptomatic carriers of the historical outbreak will be studied and compared to those present in new endemic outbreaks, as well as to those of patients already studied in a previous study. A better knowledge of parasites circulating in asymptomatic carriers will make it possible to study in a comprehensive way the risk factors associated with the parasite. In addition, the study of asymptomatic carrying in new endemic outbreaks such as Occitania is very original, since no human studies have yet been undertaken in this region. The results obtained in this PHRC will be used to understand the factors associated with the development of visceral leishmaniasis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03784248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Leishmaniasis
Currently open trials in the same condition.
- NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting
- NCT00344188 — Diagnosis and Treatment of Leishmania Infections · recruiting
Other Centre Hospitalier Universitaire de Nice trials
Trials by the same sponsor.
- NCT05897996 — Percutaneous Anastomosis Creation for Hemodialysis Access · NA · withdrawn
- NCT07499869 — INNOVATIVE BENEFITS OF A 4D VIRTUAL SIMULATOR · NA · not yet recruiting
- NCT07492251 — Upadacitinib in Adult Patients With Erosive Mucosal Lichen Planus and Lichen Planopilaris: a Prospective Multicenter Ran · Phase 2 · not yet recruiting
- NCT07511608 — Development of a New Technique for Quantifying Mitochondrial DNA in Single Muscle Fibers · NA · not yet recruiting
- NCT07582406 — Codesign, Physical Activity, and Seniors · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03784248 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre Hospitalier Universitaire de Nice
- Last refreshed: 20 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03784248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing