Efficacy of ArTiMist™ in Children

NCT01047436 | Completed Phase 2 Results DMC

• 1 other identifier: ART003
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• 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)

  The time taken for the parasite count to fall 90% from baseline

  3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h

• Time for Parasite Count to Fall by 50% PCT(50)

  The time taken for the parasite count to fall 50% from baseline

  3 h (hours) , 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h

Secondary Outcomes (3)

• Parasite Clearance Time

  3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h

• Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose

  24 hours after first dose

• Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose

  12 h (hours) after first dose

Study Arms (2)

ArTiMist (artemether sublingual spray)

EXPERIMENTAL

Drug: Artemether

Intravenous Quinine

ACTIVE COMPARATOR

Drug: Quinine

Interventions

Quinine DRUG

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

Intravenous Quinine

Artemether DRUG

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

Also known as: ArTiMist™

ArTiMist (artemether sublingual spray)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Positive RDT (rapid diagnostic test)for malaria
• The patient has either
• severe or complicated malaria as determined by the Investigator based on the WHO criteria for severity, or
• the patient has uncomplicated malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Proto Pharma Ltd: lead
• Xidea Solutions Limited: collaborator

Related Publications (1)

• 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.

  PMID: 26303805 DERIVED

MeSH Terms

Conditions

Malaria, Falciparum; Malaria; Protozoan Infections; Parasitic Diseases

Interventions

Quinine; Artemether

Condition Hierarchy (Ancestors)

Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Cinchona Alkaloids; Alkaloids; Heterocyclic Compounds; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Results Point of Contact

• Title: Dr D Bendel
• Organization: Xidea Solutions Limited

daryl@xideasolutions.com

Study Officials

• Daryl Bendel, MBChB MBA Dip Pharm Med MFPM

  Xidea Solutions Limited

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: December 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 27, 2011
• Results First Posted: January 14, 2011

Record last verified: 2011-01