Efficacy of ArTiMist™ in Children

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Falciparum Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ArTiMist (artemether sublingual spray)

Group Type EXPERIMENTAL

Artemether

Intervention Type DRUG

Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Intravenous Quinine

Group Type ACTIVE_COMPARATOR

Quinine

Intervention Type DRUG

20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy

Interventions

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Quinine

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

Artemether

Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Intervention Type DRUG

Other Intervention Names

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ArTiMist™

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No