Clinical trial NCT01047436: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Proto Pharma Ltd
Sponsor class: INDUSTRY
Collaborators: name: Xidea Solutions Limited
First posted: 2010-01-12
Enrollment: 31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose
timeFrame: 24 hours after first dose
measure: Time for Parasite Count to Fall by 90% PCT(90)
timeFrame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
measure: Time for Parasite Count to Fall by 50% PCT(50)
timeFrame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
Secondary outcomes:
measure: Parasite Clearance Time
timeFrame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h
measure: Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose
timeFrame: 24 hours after first dose
measure: Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose
timeFrame: 12 h (hours) after first dose
Other outcomes:
Locations:
Study officials:
affiliation: Xidea Solutions Limited
name: Daryl Bendel, MBChB MBA Dip Pharm Med MFPM
role: STUDY_DIRECTOR
References:
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.