Status:
COMPLETED
Efficacy and Safety of Pyronaridine-Artesunate Versus Artemether-Lumefantrine
Lead Sponsor:
University of Ibadan
Collaborating Sponsors:
Shin Poong Pharm Co Ltd 161 yoksam-ro, Gangnam-Gu Seoul 135-925, Korea
Institute for Advanced Medical Research and Training, University of Ibadan, Ibadan
Conditions:
Malaria Fever
Plasmodium Falciparum Malaria
Eligibility:
All Genders
3-144 years
Phase:
PHASE2
PHASE3
Brief Summary
In Nigeria, malaria is the commonest reason for outpatient clinic attendance in childhood and is responsible for about 20% of childhood deaths. The emergence of strains of P. falciparum resistant to c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT05192265
Start Date
May 20 2019
End Date
December 23 2020
Last Update
April 7 2022
Active Locations (1)
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1
Ikeoluwapo O Ajayi
Ibadan, Oyo State, Nigeria, 200212