Efficacy of ArTiMist™ in Children

This study has been completed.
Sponsor:
Collaborator:
Xidea Solutions Limited
Information provided by:
Proto Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01047436
First received: January 8, 2010
Last updated: January 26, 2011
Last verified: January 2011

January 8, 2010
January 26, 2011
December 2009
January 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • Time for Parasite Count to Fall by 90% PCT(90) [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The time taken for the parasite count to fall 50% from baseline
Same as current
Complete list of historical versions of study NCT01047436 on ClinicalTrials.gov Archive Site
  • Parasite Clearance Time [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
  • Parasite reduction ratio (PRR) at 12h and 24h after the first dose [ Time Frame: 12 and 24 h after first dose ] [ Designated as safety issue: No ]
  • Parasite clearance time [ Time Frame: 3h, 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of ArTiMist™ in Children
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Falciparum Malaria
  • 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
    Other Name: ArTiMist™
  • Experimental: ArTiMist (artemether sublingual spray)
    Intervention: Drug: Artemether
  • Active Comparator: Intravenous Quinine
    Intervention: Drug: Quinine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01047436
ART003
Yes
Mr Clive Booles Director of Development, ProtoPharma
Proto Pharma Ltd
Xidea Solutions Limited
Study Director: Daryl Bendel, MBChB MBA Dip Pharm Med MFPM Xidea Solutions Limited
Proto Pharma Ltd
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP