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Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

NCT01258049 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2014-02-28

Study results available
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Summary

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

Artemether Sublingual Spray

Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints

DRUG

Quinine

Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours

Sponsors & Collaborators

  • Proto Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Daryl Bendel, MBChB MFPM · Xidea Solutions Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Burkina Faso
  • Ghana
  • Rwanda

Study Locations

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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 NCT01258049 on ClinicalTrials.gov