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

Phase 3

Completed

• Conditions: Malaria
• Interventions: Drug: Pyronaridine-artesunate; Drug: Artemether-lumefantrine combination

• Registration Number: NCT02411994
• Lead Sponsor: Royal Tropical Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-03
• Study First Submitted QC: 2015-04-07
• Study First Posted: 2015-04-08
• Study Start: 2015-10
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pyronaridine-artesunate	Pyronaridine-artesunate	pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
Artemether-lumefantrine	Artemether-lumefantrine combination	artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

Primary Outcome Measures

Name	Time	Method
PCR-corrected adequate clinical and parasitological response (ACPR)	day 28 after initial dose

Secondary Outcome Measures

Name	Time	Method
parasite clearance time	up to 7 days after initial dose
transmission potential to mosquitos	day 7 after initial dose
PCR-corrected adequate clinical and parasitological response (ACPR)	day 42 after initial dose
crude adequate clinical and parasitological response (ACPR)	day 28, day 42 after initial dose
gametocyte clearance time	up to 7 days after initial dose

Trial Locations

Locations (1)

St. Jude's Clinic, ICIPE; 🇰🇪 Mbita, Kenya