Efficacy of ArTiMist™ in Children

Proto Pharma

Status and phase: Completed; Phase 2

Conditions: Falciparum Malaria

Treatments: Drug: Artemether; Drug: Quinine

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01047436

ART003

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

ArTiMist (artemether sublingual spray)

Experimental group

Treatment:

Drug: Artemether

Intravenous Quinine

Active Comparator group

Treatment:

Drug: Quinine