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

NCT ID: NCT02411994

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pyronaridine-artesunate

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

Group Type EXPERIMENTAL

Pyronaridine-artesunate

Intervention Type DRUG

Artemether-lumefantrine

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

Group Type ACTIVE_COMPARATOR

Artemether-lumefantrine combination

Intervention Type DRUG

Interventions

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Pyronaridine-artesunate

Intervention Type DRUG

Artemether-lumefantrine combination

Intervention Type DRUG

Other Intervention Names

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Pyramax Coartem

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Tropical Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Sawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

International Centre of Insect Physiology and Ecology (ICIPE)

Locations

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St. Jude's Clinic, ICIPE

Mbita, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 29866116 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29764419 (View on PubMed)

Other Identifiers

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KIT601714

Identifier Type: -

Identifier Source: org_study_id