MalariaPhase 3PAALNCT02411994

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

A Phase 3 study testing Pyronaridine-artesunate and Artemether-lumefantrine combination in people with Malaria, run by Royal Tropical Institute at 1 site in Kenya.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 months to 12 years
Conditions the study is for: Malaria
What is being tested?: Pyronaridine-artesunate and Artemether-lumefantrine combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 197 participants
Where: 1 siteKenya
Study dates: Oct 2015to Aug 2017
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Kenya1 site

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

Other trials in Kenya

About this study

Official title: 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.

Conditions: Malaria
Being tested: Pyronaridine-artesunate, Artemether-lumefantrine combination
Medical subject headings: Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pyronaridine-artesunateDrug
Also called Pyramax
Artemether-lumefantrine combinationDrug
Also called Coartem

Study groups in NCT02411994
Study group	Role	What they receive
Pyronaridine-artesunate	Experimental	pyronaridine-artesunate: recommended dose according to body weight, once a day for three days. Receives: Drug: Pyronaridine-artesunate
Artemether-lumefantrine	Active comparator	artemether-lumefantrine: recommended dose according to body weight, twice a day for three days. Receives: Drug: Artemether-lumefantrine combination

What is being measured

The primary outcome is the main question the study is designed to answer.

PCR-corrected adequate clinical and parasitological response (ACPR)
Measured: day 28 after initial dose

Secondary outcomes (5)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Aug 2017

First posted8 Apr 2015 (estimated)
Study startOct 2015
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for MalariaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 197 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02411994
Sponsor's protocol ID: KIT601714
Acronym: PAAL
Status last verified: Nov 2017
First submitted: 3 Apr 2015
Last updated: 27 Nov 2017
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 29866116
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.
PubMed 29764419

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Uncomplicated Falciparum Malaria in Western Kenya
ClinicalTrials.gov ID: NCT02411994
Acronym / sponsor ID: PAAL / KIT601714
Conditions: Malaria
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 197 participants (actual)
Lead sponsor: Royal Tropical InstituteUniversity, hospital or other
Study start: Oct 2015
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 8 Apr 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pyronaridine-artesunate	Experimental	Drug: Pyronaridine-artesunatepyronaridine-artesunate: recommended dose according to body weight, once a day for three days.
Artemether-lumefantrine	Active comparator	Drug: Artemether-lumefantrine combinationartemether-lumefantrine: recommended dose according to body weight, twice a day for three days.

Who may qualify

Ages: 6 months to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (10 listed)

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));

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pyronaridine-artesunateAlso: Pyramax	Drug	Pyronaridine-artesunate
Artemether-lumefantrine combinationAlso: Coartem	Drug	Artemether-lumefantrine

Primary outcome

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

5 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
Derived from this study: PubMed 29866116Roth 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.
Derived from this study: PubMed 29764419Roth 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.

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Iron Deficiencies
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patrick Sawa, MD, PhD principal investigator

International Centre of Insect Physiology and Ecology (ICIPE)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pyronaridine-artesunate and Artemether-lumefantrine combination in people with Malaria, run by Royal Tropical Institute at 1 site in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PCR-corrected adequate clinical and parasitological response (ACPR) (time frame: day 28 after initial dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02411994, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.