Skip to main content
OpenTrials
Completed

NCT Number: NCT01047436

Efficacy of ArTiMist™ in Children

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Falciparum Malaria Infections Malaria Malaria, Falciparum Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient's parent or attendant relative has provided informed consent and the patient has assented (where relevant) to participation in the trial
  • The patient is a child that weighs between 5 and 15 kg (kilogram)
  • The patient has falciparum malaria as evidenced by
  • 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
  • Positive RDT (rapid diagnostic test)for malaria
  • The patient has either
  • severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
  • 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

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

Treatment and study plan

Quinine

Drug

20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy

Artemether

Drug

Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Other names: ArTiMist™

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Proto Pharma Ltd

Industry

Collaborators

  • Xidea Solutions Limited

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 12, 2010
Registry last updated
Jan 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.