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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 3
Locations
Kenya
Study Type
Interventional
Intervention
Pyronaridine-artesunate
Artemether-lumefantrine combination
Sponsored by
Royal Tropical Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

6 Months - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Jude's Clinic, ICIPE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pyronaridine-artesunate

Artemether-lumefantrine

Arm Description

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

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

Outcomes

Primary Outcome Measures

PCR-corrected adequate clinical and parasitological response (ACPR)

Secondary Outcome Measures

PCR-corrected adequate clinical and parasitological response (ACPR)
crude adequate clinical and parasitological response (ACPR)
parasite clearance time
gametocyte clearance time
transmission potential to mosquitos

Full Information

First Posted
April 3, 2015
Last Updated
November 24, 2017
Sponsor
Royal Tropical Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02411994
Brief Title
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria
Acronym
PAAL
Official Title
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Tropical Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pyronaridine-artesunate
Arm Type
Experimental
Arm Description
pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
Arm Title
Artemether-lumefantrine
Arm Type
Active Comparator
Arm Description
artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.
Intervention Type
Drug
Intervention Name(s)
Pyronaridine-artesunate
Other Intervention Name(s)
Pyramax
Intervention Type
Drug
Intervention Name(s)
Artemether-lumefantrine combination
Other Intervention Name(s)
Coartem
Primary Outcome Measure Information:
Title
PCR-corrected adequate clinical and parasitological response (ACPR)
Time Frame
day 28 after initial dose
Secondary Outcome Measure Information:
Title
PCR-corrected adequate clinical and parasitological response (ACPR)
Time Frame
day 42 after initial dose
Title
crude adequate clinical and parasitological response (ACPR)
Time Frame
day 28, day 42 after initial dose
Title
parasite clearance time
Time Frame
up to 7 days after initial dose
Title
gametocyte clearance time
Time Frame
up to 7 days after initial dose
Title
transmission potential to mosquitos
Time Frame
day 7 after initial dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Sawa, MD, PhD
Organizational Affiliation
International Centre of Insect Physiology and Ecology (ICIPE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Jude's Clinic, ICIPE
City
Mbita
ZIP/Postal Code
30-40305
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
29866116
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.
Results Reference
derived
PubMed Identifier
29764419
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.
Results Reference
derived

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

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