Efficacy of ArTiMist™ in Children

Falciparum Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047436
• Other study ID #: ART003
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: January 26, 2011
• Start date: December 2009
• Est. completion date: January 2010

Study information

• Verified date: January 2011
• Source: Proto Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Rwanda: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Falciparum Malaria
• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Quinine
20 mg/kg intravenous quinine loading dose, followed by 10 mg/kg intravenously every 8 hours until resumption of normal oral therapy
• Artemether
Artemether sublingual spray 3 mg/kg at protocol specified timepoints until resumption of normal oral therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Proto Pharma Ltd	Xidea Solutions Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Parasite Clearance Time	Time in hours from the initiation of therapy until the first of two successive parasite-negative smears were obtained	3h (hours), 6h, 12h, 18h, 24h, 30h, 36h, 48h, 54h, 60h	No
Secondary	Parasite Reduction Ratio (PRR) at 24 h (Hours) After the First Dose	Reduction in parasitaemia from baseline at 24 h after the first dose of study medication	24 hours after first dose	No
Secondary	Parasite Reduction Ratio (PRR) at 12 Hours After the First Dose	Reduction in parasitaemia from baseline at 12 hours after the first dose of study medication	12 h (hours) after first dose	No