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
  Purpose

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.


Condition Intervention Phase
Falciparum Malaria
Drug: Quinine
Drug: Artemether
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Proto Pharma Ltd:

Primary Outcome 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 ] [ 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


Secondary Outcome Measures:
  • 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


Enrollment: 31
Study Start Date: December 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ArTiMist (artemether sublingual spray) Drug: Artemether
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Other Name: 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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047436

Sponsors and Collaborators
Proto Pharma Ltd
Xidea Solutions Limited
Investigators
Study Director: Daryl Bendel, MBChB MBA Dip Pharm Med MFPM Xidea Solutions Limited
  More Information

No publications provided

Responsible Party: Mr Clive Booles Director of Development, ProtoPharma
ClinicalTrials.gov Identifier: NCT01047436     History of Changes
Other Study ID Numbers: ART003
Study First Received: January 8, 2010
Results First Received: September 29, 2010
Last Updated: January 26, 2011
Health Authority: Rwanda: Ethics Committee

Keywords provided by Proto Pharma Ltd:
Plasmodium infections
Remittent fever
Artemether
Artemisinins
quinine
Malaria
Protozoan Infections
Anti-Infective Agents
Antiprotozoal Agents
Schistosomicides
Pharmacologic Actions
Malaria, Falciparum
Antimalarials
Antiparasitic Agents
Parasitic Diseases
sublingual

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Quinine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on September 18, 2014