- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05192265
Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine
Comparative Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine in The Treatment of Acute Uncomplicated Malaria Among Children In South-West Nigeria
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
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Oyo
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Ibadan, Oyo, Nigeria, 200212
- Ikeoluwapo O Ajayi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Individuals of either gender between the ages of 3months (but weight ≥5 kg) and 12 years who present with symptoms compatible with acute uncomplicated malaria
- Minimum asexual parasite density of 1000/µl. This will be done at enrolment for all study participants.
- Fever with an axillary temperature≥ 37.5°C or history of fever within 24hours of presentation
- Residence within 15 kilometres to the study site.
- Ability to take drugs orally.
- Absence of history of ACT intake in the two weeks prior to enrolment
- A signed informed consent from parents or guardians of the prospective enrollee to participate in the study
Exclusion Criteria:
- History of allergy to study drugs i.e. artemisinins, lumefantrine and pyronaridine
- Any concurrent illness that could hamper evaluation of response e.g. bacterial infections, viral infections, severe gastrointestinal disease, malnutrition (weight for height <70%).
- Presence of clinical evidence of severe malaria such as prostration, inability to drink or breastfeed, persistent vomiting, convulsion, severe anaemia haemoglobin <5 g/dl), unarousable coma
- Patients with known chronic diseases like chronic kidney disease, chronic liver disease, malnutrition, cardiac failure, Sickle Cell haemoglobin (HbSS) etc.
- Mixed or mono-infection with another Plasmodium species detected by microscopy;
- presence of severe malnutrition defined as a child aged between 6-60 months whose weight-for-high is below -3 z-score, or has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm).
- Parent or guardian who in the judgment of the investigator will not comply with protocol in the opinion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pyramax™
Artesunate-pyronaridine is indicated for the blood-stage treatment of the two dominant strains of malaria: P. falciparum and P. vivax.
The medicine is also available in a child-friendly granule formulation to enhance palatability in this vulnerable population.
Dosing was administered according to body weight: 5 - <8kg - one sachet daily for 3 days; 8 - <15Kg - two sachets daily for 3 days; 15 - <20 Kg - three sachets daily for 3 days; 20 - <24 Kg - one tablet daily for 3 days; and 24 - <45 Kg - two tablets daily for 3 days.
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The main interventions investigated are pyronaridine-artesunate granules or tablets (Pyramax™) manufactured by Shin Poong Pharmaceuticals, Seoul, Korea.
Pyramax granules come in sachets with each containing 60mg of pyronaridine/20mg of artesunate while Pyramax tablets contain 180mg pyronaridine/60mg artesunate.
Other Names:
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Active Comparator: Coartem™
We used the standard six-dose regimen of artemether-lumefantrine dispersible tablets twice daily according to body weights. Each dispersible tablet contains 20mg of artemether/120mg of lumefantrine) and the patients were dosed as follows: 5 -<15Kg one tablet, 15 - <25 Kg two tablets, 25 - <35 Kg three tablets, and ≥35 Kg four tablets at the following dosing intervals:
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Artemether-lumefantrine dispersible tablets (Coartem™, Novartis pharma) twice daily according to body weights.
Each dispersible tablet of AL contains 20mg of artemether/120mg of lumefantrine).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCR-adjusted adequate clinical and parasitological response (ACPR)
Time Frame: Treatment day 3 to 28
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Defined as absence of patent parasitaemia, regardless of axillary temperature and without evidence of previous treatment failure up to day 28.
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Treatment day 3 to 28
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate clinical and parasitological response without correction for reinfection
Time Frame: day 28
|
Adequate clinical and parasitological response (ACPR; absence of parasitaemia on day 28 without previously meeting criteria for ETF, LCF, or LPF). Note: ETF: Early treatment failure defined as danger signs or complicated malaria or failure to adequately respond to therapy on days 0-3. LCF: Late clinical failure defined as danger signs or complicated malaria or fever and parasitaemia on days 4-28 without previously meeting criteria for ETF or LPF. LPF: Late parasitological failure defined as asymptomatic parasitaemia on days 7-28 without previously meeting criteria for ETF or LCF. |
day 28
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Parasite clearance time
Time Frame: Treatment day 0 to 28
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Time from first dose of ACT until first total and continued disappearance of asexual parasite forms.
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Treatment day 0 to 28
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Fever clearance time
Time Frame: Treatment day 0 to 28
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Time from first dose until the first time the body temperature (for those with a raised temperature at enrolment) decrease to below 37.5 degree Celsius and remain so for at least 24 hours.
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Treatment day 0 to 28
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Gametocyte carriage
Time Frame: Treatment day 0 to 28
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Proportions of patients with gametocyte at a given point in time.
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Treatment day 0 to 28
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine O Falade, MB.BS, MSc, FMCP, FWACP, MD, University of Ibadan; Consultant Clinical Pharmacologist, University College Hospital, Ibadan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Falciparum
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Lumefantrine
- Artemether
- Artesunate
- Artemether, Lumefantrine Drug Combination
- Pyronaridine
- Antimalarials
Other Study ID Numbers
- UI/EC/19/0114
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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