Efficacy of ArTiMist™ in Children - Full Text View

Purpose

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.

Condition	Intervention	Phase
Falciparum Malaria	Drug: Quinine Drug: Artemether	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Malaria Parasitic Diseases

Drug Information available for: Quinine Quinine Sulfate Artemether

U.S. FDA Resources

Further study details as provided by Proto Pharma Ltd:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Time for Parasite Count to Fall by 90% PCT(90) [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
The time taken for the parasite count to fall 90% from baseline
Time for Parasite Count to Fall by 50% PCT(50) [ Time Frame: 3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
The time taken for the parasite count to fall 50% from baseline

Secondary Outcome Measures:

Parasite Clearance Time [ Time Frame: 3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h ] [ Designated as safety issue: No ]
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 [ Time Frame: 24 hours after first dose ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 h (hours) after first dose ] [ Designated as safety issue: No ]
Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication

Enrollment:	31
Study Start Date:	December 2009
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ArTiMist (artemether sublingual spray)	Drug: Artemether Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy Other Name: ArTiMist™
Active Comparator: Intravenous Quinine	Drug: Quinine 20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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
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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01047436

Sponsors and Collaborators

Proto Pharma Ltd

Xidea Solutions Limited

Investigators

Study Director:

Daryl Bendel, MBChB MBA Dip Pharm Med MFPM

Xidea Solutions Limited

More Information

No publications provided

Responsible Party:	Mr Clive Booles Director of Development, ProtoPharma
ClinicalTrials.gov Identifier:	NCT01047436 History of Changes
Other Study ID Numbers:	ART003
Study First Received:	January 8, 2010
Results First Received:	September 29, 2010
Last Updated:	January 26, 2011
Health Authority:	Rwanda: Ethics Committee

Keywords provided by Proto Pharma Ltd:

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

Additional relevant MeSH terms:

Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artemether
Anti-Infective Agents
Quinine
Antiparasitic Agents
Antiprotozoal Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Muscle Relaxants, Central

Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics

ClinicalTrials.gov processed this record on May 23, 2013