ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
Recruiting
Phase 2
Phase 3
Interventional Study
Lassa Fever
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 1,755 (estimated)
- Sponsor
- Irrua Specialist Teaching Hospital · Other
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About This Trial
Lassa fever (LF) is a viral haemorrhagic fever responsible of 5000 deaths per year in West Africa, with in-hospital mortality at 12%. Transmission to humans occurs mainly via direct or indirect exposure to excreta from the rodent reservoir, mainly made up of Mastomys natalensis . Less frequently, LASV may also be transmitted from human to human and cause nosocomial outbreaks. Ribavirin is the only…
Trial Locations
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Eligibility Criteria
1. General
Inclusion criteria
* Clinical disease with signs and symptoms suggestive for LF
* Positive plasma LASV RT-PCR
* Participant requires hospitalization per the local guidelines
* Participant or their legally authorized representative is able and willing to sign the informed c…
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