Efficacy of ArTiMist™ in Children

Phase 2

Completed

• Conditions: Falciparum Malaria
• Interventions: Drug: Artemether; Drug: Quinine

• Registration Number: NCT01047436
• Lead Sponsor: Proto Pharma Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Results First Submitted: 2010-09-29
• Results First Submitted QC: 2010-12-13
• Status Verified: 2011-01
• Results First Posted: 2011-01-14
• Last Update Submitted: 2011-01-26
• Last Update Posted: 2011-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ArTiMist (artemether sublingual spray)	Artemether	-
Intravenous Quinine	Quinine	-

Primary Outcome Measures

Name	Time	Method
Parasitological Success Defined as a Reduction in Parasite Count of ≥ 90% of Baseline at 24 Hours After the First Dose	24 hours after first dose
Time for Parasite Count to Fall by 90% PCT(90)	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)	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 Outcome Measures

Name	Time	Method
Parasite Clearance Time	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	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	12 h (hours) after first dose	Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication