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Completed

NCT Number: NCT02411994

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

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.

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St. Jude's Clinic, ICIPE

Mbita, 30-40305, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pyronaridine-artesunate

Drug

Other names: Pyramax

Artemether-lumefantrine combination

Drug

Other names: Coartem

Primary outcomes

  1. PCR-corrected adequate clinical and parasitological response (ACPR)

    Time frame: day 28 after initial dose

Secondary outcomes

  1. PCR-corrected adequate clinical and parasitological response (ACPR)

    Time frame: day 42 after initial dose

  2. crude adequate clinical and parasitological response (ACPR)

    Time frame: day 28, day 42 after initial dose

  3. parasite clearance time

    Time frame: up to 7 days after initial dose

  4. gametocyte clearance time

    Time frame: up to 7 days after initial dose

  5. transmission potential to mosquitos

    Time frame: day 7 after initial dose

Sponsors and collaborators

Lead sponsor

Royal Tropical Institute

Other

Registry information

Official study title

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

Acronym: PAAL

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 8, 2015
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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