NCT02411994

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

1.8 years

First QC Date

April 3, 2015

Last Update Submit

November 24, 2017

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • PCR-corrected adequate clinical and parasitological response (ACPR)

    day 28 after initial dose

Secondary Outcomes (5)

  • 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

  • parasite clearance time

    up to 7 days after initial dose

  • gametocyte clearance time

    up to 7 days after initial dose

  • transmission potential to mosquitos

    day 7 after initial dose

Study Arms (2)

Pyronaridine-artesunate

EXPERIMENTAL

pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.

Drug: Pyronaridine-artesunate

Artemether-lumefantrine

ACTIVE COMPARATOR

artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

Drug: Artemether-lumefantrine combination

Interventions

Pyronaridine-artesunateDRUG
Also known as: Pyramax
Pyronaridine-artesunate
Artemether-lumefantrine combinationDRUG
Also known as: Coartem
Artemether-lumefantrine

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude's Clinic, ICIPE

Mbita, 30-40305, Kenya

Location

Related Publications (2)

  • 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.

    PMID: 29866116DERIVED

  • 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.

    PMID: 29764419DERIVED

MeSH Terms

Conditions

Malaria

Interventions

pyronaridine tetraphosphate, artesunate drug combinationArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Patrick Sawa, MD, PhD

    International Centre of Insect Physiology and Ecology (ICIPE)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2015

First Posted

April 8, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Locations

KE(1)