Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With… (NCT04368910) | Clinical Trial Compass
TerminatedPhase 3
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
Stopped: Due to slow recruitment the study was terminated prematurely by the Sponsor after 30 subjects had been included
South Korea30 participantsStarted 2007-09-06
Plain-language summary
The primary objective of this clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax (P. vivax) malaria
Who can participate
Age range3 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female patients between the age of 3 and 60 years, inclusive.
✓. Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.
✓. Presence of acute uncomplicated P. vivax mono-infection confirmed by:
✓. Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
✓. Positive microscopy of P. vivax with parasite density ≥250/ μL of blood (including at least 50% of asexual parasites).
✓. Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations.
✓. Ability to swallow oral medication.
✓. Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.
Exclusion criteria
✕. Presence of a mixed Plasmodium infection.
✕. Presence of other clinical condition requiring hospitalization.
✕. Presence of significant anaemia, as defined by Hb \<8 g/dL.
✕. Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).