Efficacy of ArTiMist™ in Children

January 26, 2011 updated by: Proto Pharma Ltd

An Open Label Randomised Comparative Trial to Establish the Efficacy of 3 mg/kg ArTiMist™ When Compared to Intravenous Quinine in Children With Severe or Complicated Falciparum Malaria, or Uncomplicated Falciparum Malaria With Gastrointestinal Complications

The purpose of this study is to compare the efficacy of Artemether Sublingual Spray (ArTiMist™) with intravenous quinine in children with severe or complicated falciparum malaria, or children with uncomplicated malaria with gastrointestinal complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
  2. The patient is a child that weighs between 5 and 15 kg (kilogram)

  3. The patient has falciparum malaria as evidenced by

    1. Thick or thin blood smears of > 500 P falciparum per mcl (microlitre)(patients with mixed infections may be included provided >500 P Falciparum /mcl) and /or
    2. Positive RDT (rapid diagnostic test)for malaria

  4. The patient has either

    1. severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
    2. the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

Exclusion Criteria:

  1. Attending relative or parent does not provide informed consent for participation, or the child if capable does not assent to participation in the trial.
  2. Ability to tolerate oral therapy
  3. Patient has received any treatment with an artemisinin or quinine in the last 24 hours
  4. Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
  5. Patient is allergic or intolerant to artemisinins.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ArTiMist (artemether sublingual spray)
Drug: Artemether
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Other Names:
  • ArTiMist™
Active Comparator: Intravenous Quinine
Drug: Quinine
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
Time Frame: 24 hours after first dose
24 hours after first dose
Time for Parasite Count to Fall by 90% PCT(90)
Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 90% from baseline
3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Time for Parasite Count to Fall by 50% PCT(50)
Time Frame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
The time taken for the parasite count to fall 50% from baseline
3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parasite Clearance Time
Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained
3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose
Time Frame: 24 hours after first dose
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication
24 hours after first dose
Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose
Time Frame: 12 h (hours) after first dose
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
12 h (hours) after first dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proto Pharma Ltd

Collaborators

Xidea Solutions Limited

Investigators

  • Study Director: Daryl Bendel, MBChB MBA Dip Pharm Med MFPM, Xidea Solutions Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 27, 2011

Last Update Submitted That Met QC Criteria

January 26, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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