Superiority of ArTiMist Versus Quinine in Children With Severe Malaria

NCT01258049 | Completed Phase 3 Results DMC

• 1 other identifier: ART004
• Study Type: interventional
• Target: 151
• Locations: 3 countries
• Sites: 3

Brief Summary

The purpose of this study is to demonstrate that ArTiMist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

Conditions

Plasmodium Falciparum Malaria

Keywords

Plasmodium infections; Remittent fever; Artemether; Artemesinins; Quinine; Malaria; Protozoan infections; sublingual drug delivery; Parasitic disease; Antiprotozoan agents

Outcome Measures

Primary Outcomes (2)

• Parasitological Success (MITT)

  Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose

  24 hours after start of treatment

• Parasitological Success (PP)

  Parasitological success defined as a reduction in parasite count of ≥ 90% of baseline at 24 hours after the first dose

  24 hours after start of treatment

Secondary Outcomes (14)

• Parasite Clearance Time (PCT) [MITT Population]

  28 days after start of treatment

• PCT 90 [MITT Population]

  28 days after start of treatment

• PCT 50 [MITT Population]

  28 days after start of treatment

• PRR 24 [MITT Population]

  28 days after start of treatment

• PRR 12 [MITT Population]

  28 days after start of treatment

Study Arms (2)

ArTiMist

EXPERIMENTAL

Drug: Artemether Sublingual Spray

Quinine

ACTIVE COMPARATOR

Drug: Quinine

Interventions

Artemether Sublingual Spray DRUG

Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints

Also known as: ArTiMist

ArTiMist

Quinine DRUG

Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours

Quinine

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 legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial
• The patient is a child that weighs between 5.00 kg and 15.00 kg inclusive
• The patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 P Falciparum per mcl (patients with mixed infections may be included provided ≥ 500 P Falciparum per mcl)
• The patient has either:
• severe or complicated falciparum malaria as determined by the investigator based on the WHO criteria for severity, and/or
• uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea.

You may not qualify if:

• The patient's legally acceptable representative 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 antimalarial therapy within the 7 days prior to first study drug administration.
• Patient has evidence of significant co-infections (this does not include mixed Plasmodium infections).
• Patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .

Sponsors & Collaborators

• Proto Pharma Ltd: lead

Study Sites (3)

Centre National de Recherche et de Formation sur le Paludisme (CNRFP)

Ouagadougou, 01 BP 2208, Burkina Faso

Location

Navrongo Health Research Centre

Navrongo, Navrongo, P.O. Box 114, Ghana

Location

Rwinkwavu District Hospital

Rwinkwavu, Eastern Province, Rwanda

Location

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

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

Results Point of Contact

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

daryl@xideasolutions.com

Study Officials

• Daryl Bendel, MBChB MFPM

  Xidea Solutions Limited

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 10, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 28, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-01

Locations

GH (1); BU (1); RW (1)