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Oral ARV-1801 Given in Combination With Intravenous Ceftazidime or Meropenem for Treatment of Melioidosis in Hospitalized Patients

NCT05105035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-02-16

No results posted yet for this study

Summary

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.

Conditions

  • Melioidosis

Interventions

DRUG

Ceftazidime or meropenem

Patients will be prescribed ceftazidime or meropenem intravenously as per standard of care for at least 14 days while in the hospital

DRUG

ARV-1801

Patients will be prescribed ARV-1801 at 1500mg 12 hours apart on Day 1 and 600mg every 12 hours for Days 2-14.

DRUG

Placebo

Patients will be prescribed placebo every 12 hours for Days 1-14.

Sponsors & Collaborators

  • Arnasi Group

    collaborator UNKNOWN

  • Arrevus Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-10-10
Completion
2023-10-10
FDA Drug
Yes

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05105035 on ClinicalTrials.gov