Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria

Malaria Clinical Trial

— PAAL  

Official title:

Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411994
• Other study ID #: KIT601714
• Status: Completed
• Phase: Phase 3
• First received: April 3, 2015
• Last updated: November 24, 2017
• Start date: October 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2017
• Source: Royal Tropical Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 12 Years

Eligibility

Inclusion Criteria:

• Children between 6 months and 12 years old, with a body weight of =5 kg;

• Living in the catchment area of the study (within a radius of ~10 km from St. Jude's Clinic, Mbita, Kenya);

• Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1).

Exclusion Criteria:

• Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;

• Mixed Plasmodium infection;

• Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);

• Having anaemia with an Hb <6 g/dL;

• Evidence of severe malnutrition (severe wasting: z-score weight for age <-3 and severe stunting: z-score height for age <-3 (WHO 2009b));

• Having received anti-malarial therapy in the previous two weeks;

• Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;

• Participating in other anti-malarial drug intervention studies;

• Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);

• Not being available for follow-up.

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Pyronaridine-artesunate

• Artemether-lumefantrine combination

Locations

Country	Name	City	State
Kenya	St. Jude's Clinic, ICIPE	Mbita

Sponsors (1)

Lead Sponsor	Collaborator
Royal Tropical Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR-corrected adequate clinical and parasitological response (ACPR)		day 28 after initial dose
Secondary	PCR-corrected adequate clinical and parasitological response (ACPR)		day 42 after initial dose
Secondary	crude adequate clinical and parasitological response (ACPR)		day 28, day 42 after initial dose
Secondary	parasite clearance time		up to 7 days after initial dose
Secondary	gametocyte clearance time		up to 7 days after initial dose
Secondary	transmission potential to mosquitos		day 7 after initial dose