Back to resultsEfficacy of ArTiMist™ in Children
Primary Purpose
Falciparum Malaria
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Quinine
Artemether
Sponsored by
About this trial
This is an interventional treatment trial for Falciparum Malaria focused on measuring 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
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ArTiMist (artemether sublingual spray)
Intravenous Quinine
Arm Description
Outcomes
Primary Outcome Measures
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
Time for Parasite Count to Fall by 90% PCT(90)
The time taken for the parasite count to fall 90% from baseline
Time for Parasite Count to Fall by 50% PCT(50)
The time taken for the parasite count to fall 50% from baseline
Secondary Outcome Measures
Parasite Clearance Time
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
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
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
Full Information
NCT ID
NCT01047436
First Posted
January 8, 2010
Last Updated
January 26, 2011
Sponsor
Proto Pharma Ltd
Collaborators
Xidea Solutions Limited
1. Study Identification
Unique Protocol Identification Number
NCT01047436
Brief Title
Efficacy of ArTiMist™ in Children
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Proto Pharma Ltd
Collaborators
Xidea Solutions Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Falciparum Malaria
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ArTiMist (artemether sublingual spray)
Arm Type
Experimental
Arm Title
Intravenous Quinine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Quinine
Intervention Description
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
Intervention Type
Drug
Intervention Name(s)
Artemether
Other Intervention Name(s)
ArTiMist™
Intervention Description
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy
Primary Outcome Measure Information:
Title
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
Title
Time for Parasite Count to Fall by 90% PCT(90)
Description
The time taken for the parasite count to fall 90% from baseline
Time Frame
3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Title
Time for Parasite Count to Fall by 50% PCT(50)
Description
The time taken for the parasite count to fall 50% from baseline
Time Frame
3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Secondary Outcome Measure Information:
Title
Parasite Clearance Time
Description
Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained
Time Frame
3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Title
Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose
Description
Reduction in parasitaemia from baseline at 24 h after the first dose of study medication
Time Frame
24 hours after first dose
Title
Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose
Description
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication
Time Frame
12 h (hours) after first dose
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daryl Bendel, MBChB MBA Dip Pharm Med MFPM
Organizational Affiliation
Xidea Solutions Limited
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26303805
Citation
Bendel D, Rulisa S, Ansah P, Sirima S. Efficacy of a novel sublingual spray formulation of artemether in African children with Plasmodium falciparum malaria. Antimicrob Agents Chemother. 2015 Nov;59(11):6930-8. doi: 10.1128/AAC.00243-15. Epub 2015 Aug 24.
Results Reference
derived
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Efficacy of ArTiMist™ in Children
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