Status:
NOT_YET_RECRUITING
ISTH/ANRS 0409s INTEGRATE Lassa Fever Study
Lead Sponsor:
Irrua Specialist Teaching Hospital
Collaborating Sponsors:
Alliance for International Medical Action
University of Bordeaux
Conditions:
Lassa Fever
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 exposu...
Detailed Description
The INTEGRATE study is a platform, multinational, multicentre, sequential, seamless phase II-III, controlled, randomised, superiority trial in open-label parallel arms. Three arms will be assessed and...
Eligibility Criteria
Inclusion
- 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 consent
- Exclusion criteria
- • Unwilling to provide informed consent
- • Positive pregnancy test
- Unwilling to provide informed consent
- History of allergic reaction or other contra-indication to ribavirin according to the Reference safety document
- Received drug therapy for Lassa fever (excluding supportive care) prior to inclusion
- Has received a vaccine against LF
- Sub-protocols
- 1 Favipiravir high dose sub-protocol
- Inclusion criteria
- • Age ≥ 18 years old
- Exclusion criteria
- • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- • Treatment contraindicated with favipiravir according to the Reference safety document
- • Pre-existing liver failure
- Severe symptomatic gout/hyperuricemia
- History of QT prolongation or arrhythmia or other cardiac disorders
- PR interval ≥ 200 ms
- Hypersensitivity to excipients
- Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 2. Favipiravir-Ribavirin sub-protocol
- Inclusion criteria
- • Age ≥ 18 years old
- Exclusion criteria
- • Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- • Treatment contraindicated with favipiravir according to the Reference safety document
- • Pre-existing liver failure
- • Severe symptomatic gout/hyperuricemia
- • History of QT prolongation or arrhythmia or other cardiac disorders
- • PR interval ≥ 200 ms
- • Hypersensitivity to excipients
- • Inability to take oral drug (e.g. encephalopathy, severe vomiting)
- 3. Dexamethasone sub-protocol
- Inclusion criteria
- • Age ≥ 12 years old
- Exclusion criteria
- Pregnancy (evidenced by positive urine pregnancy test in women of child-bearing potential)
- Known intolerance and contra-indications to ribavirin or dexamethasone
- Patients who already received a corticosteroid within the preceding 7 days
Exclusion
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
1755 Patients enrolled
Trial Details
Trial ID
NCT06212336
Start Date
July 1 2024
End Date
June 1 2027
Last Update
January 18 2024
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