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

November 24, 2017 updated by: Royal Tropical Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

197

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Mbita, Kenya, 30-40305
        • St. Jude's Clinic, ICIPE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyronaridine-artesunate
pyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
Drug: Pyronaridine-artesunate
Other Names:
  • Pyramax
Active Comparator: Artemether-lumefantrine
artemether-lumefantrine: recommended dose according to body weight, twice a day for three days.
Drug: Artemether-lumefantrine combination
Other Names:
  • Coartem

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PCR-corrected adequate clinical and parasitological response (ACPR)
Time Frame: day 28 after initial dose
day 28 after initial dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Tropical Institute

Investigators

  • Principal Investigator: Patrick Sawa, MD, PhD, International Centre of Insect Physiology and Ecology (ICIPE)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 3, 2015

First Submitted That Met QC Criteria

April 7, 2015

First Posted (Estimate)

April 8, 2015

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 24, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIT601714

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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