Clinical trial NCT02411994: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria
Official title: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Malaria
Lead sponsor: Royal Tropical Institute
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 197
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: PCR-corrected adequate clinical and parasitological response (ACPR)
timeFrame: day 28 after initial dose
Secondary outcomes:
measure: PCR-corrected adequate clinical and parasitological response (ACPR)
timeFrame: day 42 after initial dose
measure: crude adequate clinical and parasitological response (ACPR)
timeFrame: day 28, day 42 after initial dose
measure: parasite clearance time
timeFrame: up to 7 days after initial dose
measure: gametocyte clearance time
timeFrame: up to 7 days after initial dose
measure: transmission potential to mosquitos
timeFrame: day 7 after initial dose
Other outcomes:
Locations:
city: Mbita
country: Kenya
facility: St. Jude's Clinic, ICIPE
Study officials:
affiliation: International Centre of Insect Physiology and Ecology (ICIPE)
name: Patrick Sawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roth JM, Sawa P, Omweri G, Osoti V, Makio N, Bradley J, Bousema T, Schallig HDFH, Mens PF. Plasmodium falciparum gametocyte dynamics after pyronaridine-artesunate or artemether-lumefantrine treatment. Malar J. 2018 Jun 4;17(1):223. doi: 10.1186/s12936-018-2373-7.
citation: Roth JM, Sawa P, Makio N, Omweri G, Osoti V, Okach S, Choy F, Schallig HDFH, Mens P. Pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children: a randomized controlled non-inferiority trial. Malar J. 2018 May 15;17(1):199. doi: 10.1186/s12936-018-2340-3.