Efficacy of ArTiMist™ in Children

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: Quinine
    • 20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
  • Drug: Artemether
    • Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Arms, Groups and Cohorts

  • Experimental: ArTiMist (artemether sublingual spray)
  • Active Comparator: Intravenous Quinine

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Proto Pharma Ltd
  • Collaborator
    • Xidea Solutions Limited
  • Provider of Information About this Clinical Study
    • Mr Clive Booles Director of Development, ProtoPharma
  • Overall Official(s)
    • Daryl Bendel, MBChB MBA Dip Pharm Med MFPM, Study Director, Xidea Solutions Limited

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.