A Phase 2 interventional study of Ceftazidime or meropenem and ARV-1801 in Melioidosis, sponsored by Arrevus Inc.. Completed at 5 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by Arrevus Inc. · Phase 2, Interventional, and Treatment
The study investigates the effect of 14 days of twice daily doses of ARV-1801 or placebo in combination with meropenem or ceftazidime in patients hospitalized with melioidosis.
ARV-1801 is an oral dosage form and loading dose regimen of sodium fusidate. Sodium fusidate is a member of the fusidane class of antibiotics. Recent evidence demonstrates meaningful activity against multiple biothreat agents, including the intracellular pathogen B. pseudomallei, which causes melioidosis. Once melioidosis is suspected clinically, treatment typically involves intravenous antibiotics such as ceftazidime or meropenem during an initial "intensive" phase (typically 2 weeks) and oral antibiotics such as co trimoxazole during a more chronic "eradication" phase (typically 12 weeks). Nevertheless, mortality can still exceed 40% in some regions, with most deaths occurring early during the eradication phase of therapy.
The purpose of this study is to evaluate the effects of ARV-1801 administered for 14 days in conjunction with the current standard of care (meropenem or ceftazidime) against placebo in conjunction with the current standard of care. Day 1 dosing will include two doses of 1500mg of ARV-1801 or placebo administered 12 hours apart. Days 2-14 will include 600 mg doses of ARV-1801 or placebo administered every 12 hours.
Arrevus Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient must be hospitalized with suspected community-acquired melioidosis, meeting at least one of the criteria below:
Exclusion Criteria:
Patient requires concomitant treatment with the following:
Patients are administered either IV ceftazidime or IV meropenem per standard of care and placebo. Placebo will be administered every 12 hours for Days 1-14.
Drug: Ceftazidime or meropenem · Drug: Placebo
Patients are administered either IV ceftazidime or IV meropenem per standard of care and active ARV-1801. Day 1 dosing will be two doses of 1500mg of ARV-1801 administered 12 hours apart. Days 2-14 dosing will be 600mg of ARV-1801 administered every 12 hours.
Drug: Ceftazidime or meropenem · Drug: ARV-1801
Patients will be prescribed ceftazidime or meropenem intravenously as per standard of care for at least 14 days while in the hospital
Patients will be prescribed ARV-1801 at 1500mg 12 hours apart on Day 1 and 600mg every 12 hours for Days 2-14.
Patients will be prescribed placebo every 12 hours for Days 1-14.
All-cause in-hospital mortality through Day 14 in the modified intent-to-treat population (mITT)
Time frame: Measured at Day 14
All-cause in-hospital mortality in mITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
All-cause in-hospital mortality through Day 14 in the ITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
All-cause in-hospital mortality in the ITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
Clearance of positive baseline B. pseudomallei blood cultures at Day 1, 3 and 7
Time frame: Measured at Days 1, 3 and 7
Number of days in the ICU in the mITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
Number of days on ventilator in the mITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
Length of hospital stay in the mITT population
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
Melioidosis seriousness score in mITT population
Time frame: Measured at Day 28
Number of patients experiencing adverse events
Time frame: Measured at study completion, on average 28 days (assessed up to 60 days)
Plan to share: No
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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Melioidosis
Arrevus Inc.