<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03814616</url>
  </required_header>
  <id_info>
    <org_study_id>SP-C-026-18</org_study_id>
    <nct_id>NCT03814616</nct_id>
  </id_info>
  <brief_title>Pyramax in Asymptomatic Carriers of P. Falciparum Monoinfections</brief_title>
  <official_title>A Randomized, Open-Label Exploratory Study To Determine The Efficacy Of Different Treatment Regimens Of Pyramax® (Pyronaridine-Artesunate) In Asymptomatic Carriers Of Plasmodium Falciparum Monoinfections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shin Poong Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medicines for Malaria Venture</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shin Poong Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the efficacy of Pyramax administered for three-day, two-day or one&#xD;
      day, in clearing a P. falciparum infection in asymptomatic carriers.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, open-label, three-arm, out-patient study in asymptomatic individuals&#xD;
      with P. falciparum monoinfection confirmed at baseline, who are &gt;5 years of age and &gt;20kg&#xD;
      body weight. A total of 300 participants will be randomised into the study; 100 participants&#xD;
      in each of three treatment arms.&#xD;
&#xD;
      Patients who fulfil the entry criteria (all inclusion and none of the exclusion criteria)&#xD;
      will be recruited and randomized to receive Pyramax orally for three days, two days or one&#xD;
      day in a randomization ratio of 1:1:1.&#xD;
&#xD;
      All participants will be followed until Day 63 (counted from day 0) and blood samples will be&#xD;
      taken on Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42 and 63 for malaria diagnostics, parasite&#xD;
      density and qPCR. In addition, blood samples reverse-transcriptase (RT)-PCR will be taken on&#xD;
      Days 0, 1, 2, 3, 7 and 14.&#xD;
&#xD;
      Participants will be administered local SOC treatment if they meet any of the&#xD;
      protocol-specific criteria of treatment failure: Early treatment failure, Late clinical&#xD;
      failure, or Late parasitological failure up to and including Day 63, or if the participant&#xD;
      withdraws at any time before Day 63, and is parasite positive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 3, 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PCR-adjusted APR at Day 28 (based on slide assessment by microscopy)</measure>
    <time_frame>Day 28</time_frame>
    <description>To assess the efficacy of each dosing regimen PCR-adjusted Adequate parasitological response (APR) at Day 28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PCR-adjusted APR</measure>
    <time_frame>63 days</time_frame>
    <description>To assess the efficacy of each dosing regimen PCR-adjusted APR at Day 63</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PCR-unadjusted APR</measure>
    <time_frame>63 days</time_frame>
    <description>To assess the efficacy of each dosing regimen PCR-unadjusted APR at Day 63</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of recurrent infections, recrudescence and new infections</measure>
    <time_frame>63 days</time_frame>
    <description>To assess the efficacy of each dosing regimen on rate of recurrent infections, recrudescence and new infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of parasite free participants</measure>
    <time_frame>4 days</time_frame>
    <description>Proportion of participants who are parasite free by 4-8 hours, Day 1, Day 2 and Day 3 post first dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gametocyte incidence</measure>
    <time_frame>14 days</time_frame>
    <description>The area under the curve (AUC) up to Day 14 (post first dose) of gametocytes in participants with gametocytes at baseline, and separately in participants without gametocytes at baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>63 days</time_frame>
    <description>Number (%) of patients and number of events with:&#xD;
TEAEs,&#xD;
serious TEAEs,&#xD;
study drug related TEAEs,&#xD;
study drug related serious TEAEs,&#xD;
malaria-related TEAEs,&#xD;
malaria-related serious TEAEs&#xD;
Number (%) of patients with TEAEs and drug-related TEAEs by maximum severity, based on Grade 1 to Grade 5 (CTCAE V4.03) severity grading Adverse events will be coded by MedDRA primary system organ class and preferred term.&#xD;
Hepatotoxicity related TEAEs o The number and percentage of patients with hepatotoxicity related TEAEs, based on the Standard MedDRA Query (SMQ) narrow search &quot;Drug-related hepatic disorders&quot; will be summarised and clinical biochemistry parameters</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory data - Haematology</measure>
    <time_frame>63 days</time_frame>
    <description>Haemoglobin, haematocrit, erythrocytes, platelets, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory data - Biochemistry</measure>
    <time_frame>63 days</time_frame>
    <description>Total and conjugated bilirubin will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory data - Liver Enzymes</measure>
    <time_frame>63 days</time_frame>
    <description>Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST), Alkaline Phosphatase will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. IU/L units will be used to summarise the data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical laboratory data - Liver Enzyme Elevations</measure>
    <time_frame>63 days</time_frame>
    <description>The number (%) of participants with liver enzyme elevations after first drug administration as defined below will be summarised.&#xD;
ALT or AST &gt; 3 x Upper Limit of Normal (ULN)&#xD;
ALT or AST &gt; 5 x ULN&#xD;
ALT or AST &gt; 8 x ULN&#xD;
ALT or AST &gt; 3 x ULN and bilirubin &gt; 2 x ULN at the same time point (when conjugated bilirubin fraction is missing)&#xD;
ALT or AST &gt; 3 x ULN and bilirubin &gt; 2 x ULN, together with a conjugated bilirubin fraction &gt;35% (Potential Hy's law cases), at the same time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs - Blood pressure</measure>
    <time_frame>63 days</time_frame>
    <description>Supine systolic and diastolic blood pressure (mm Hg) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs - Pulse rate</measure>
    <time_frame>63 days</time_frame>
    <description>Pulse rate (bpm) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital signs - Temperature</measure>
    <time_frame>63 days</time_frame>
    <description>Temperature (degrees Celsius) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Parasite free by qPCR quantification</measure>
    <time_frame>63 days</time_frame>
    <description>To estimate the proportion of participants who are parasite free by qPCR quantification.</description>
  </other_outcome>
  <other_outcome>
    <measure>PCR-adjusted APR by qPCR</measure>
    <time_frame>63 days</time_frame>
    <description>To estimate PCR-adjusted APR by qPCR.To estimate PCR-unadjusted APR by qPCR. To estimate the rate of recurrent infections, recrudescences and new infections by qPCR until Day 63 (post first dose) by KM analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage change in gametocytaemia.</measure>
    <time_frame>63 days</time_frame>
    <description>In participants with positive detection of gametocytes by reverse transcriptase (RT)-PCR at baseline, to evaluate percentage reduction in gametocytaemia.</description>
  </other_outcome>
  <other_outcome>
    <measure>AUC of gametocytaemia by RT-PCR</measure>
    <time_frame>14 days</time_frame>
    <description>To estimate area under the curve (AUC) up to Day 14 of gametocytaemia by RT-PCR, in participants with positive RT-PCR at baseline and separately in participants with negative RT-PCR at baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Relationship between artesunate and pyronaridine concentration and efficacy</measure>
    <time_frame>28 days</time_frame>
    <description>To explore the relationship between artesunate and pyronaridine concentration and efficacy (PCR-adjusted APR at Day 28, based on slide assessment by microscopy)</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Malaria,Falciparum</condition>
  <arm_group>
    <arm_group_label>Arm Pyramax 3 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for three days (Arm A)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Pyramax 2 days</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for two days (Arm B)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm Pyramax 1 day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for one day (Arm C)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyronaridine tetraphosphate 180mg:artesunate 60mg</intervention_name>
    <description>ACT</description>
    <arm_group_label>Arm Pyramax 1 day</arm_group_label>
    <arm_group_label>Arm Pyramax 2 days</arm_group_label>
    <arm_group_label>Arm Pyramax 3 days</arm_group_label>
    <other_name>Pyramax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Evidence of asymptomatic infection with Plasmodium falciparum monoinfection on thin&#xD;
             and thick blood smears with parasite density between 20/µL and 50,000/µL&#xD;
&#xD;
          2. Absence of any clinical symptoms of malaria at the time of enrolment and within 72&#xD;
             hours before enrolment&#xD;
&#xD;
          3. Age &gt;5 years old and &gt;20 kg body weight&#xD;
&#xD;
          4. Ability to swallow oral medication&#xD;
&#xD;
          5. Evidence of a personally signed and dated Informed Consent document indicating that&#xD;
             the participant (or a legally acceptable representative if a participant is &lt;18 years&#xD;
             of age) has been informed of all pertinent aspects of the study and that all questions&#xD;
             by the participant have been sufficiently answered. Assent will be obtained from&#xD;
             participants &lt;18 years of age as required by national regulations.&#xD;
&#xD;
          6. Participants who are willing to and are able to comply with scheduled visits,&#xD;
             treatment plan, laboratory tests, and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Haemoglobin &lt;7 g/dL (measured at screening)&#xD;
&#xD;
          2. History of having received any antimalarial treatment (alone or in combination) during&#xD;
             the following periods before screening:&#xD;
&#xD;
               1. Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks&#xD;
                  prior to screening&#xD;
&#xD;
               2. Amodiaquine, chloroquine within 4 weeks prior to screening&#xD;
&#xD;
               3. Any artemisinin derivative (artesunate, artemether or dihydroartemisinin),&#xD;
                  quinine, lumefantrine or any other anti-malarial treatment or antibiotic with&#xD;
                  antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and&#xD;
                  fluoroquinolones and azithromycin) within 14 days prior to screening&#xD;
&#xD;
          3. Any herbal products or traditional medicines during the 7 days prior to screening (if&#xD;
             spontaneously reported by the patient)&#xD;
&#xD;
          4. Known allergy to the study drugs (pyronaridine and/or any artemisinin derivatives)&#xD;
&#xD;
          5. Positive urinary pregnancy test for women of reproductive age&#xD;
&#xD;
          6. Lactating women&#xD;
&#xD;
          7. Evidence of severe malnutrition&#xD;
&#xD;
          8. Participation in other studies within 30 days before the current study begins and/or&#xD;
             during study participation&#xD;
&#xD;
          9. Inability to comprehend and/or unwillingness to follow the study protocol&#xD;
&#xD;
         10. Previously randomized in this study&#xD;
&#xD;
         11. Severe acute or chronic medical or psychiatric condition or laboratory abnormality&#xD;
             that may increase the risk associated with study participation or investigational&#xD;
             product administration or may interfere with the interpretation of study results and,&#xD;
             in the judgment of the investigator, would make the participant inappropriate for&#xD;
             entry into this study. Examples would include but not limited to:&#xD;
&#xD;
               1. Immunological disorders (including known seropositive HIV antibody),&#xD;
&#xD;
               2. Severe psychiatric disorders (active depression, recent history of depression,&#xD;
                  generalised anxiety, psychosis, schizophrenia or other major psychiatric&#xD;
                  disorders) and major medical disorders related to cardiovascular, respiratory&#xD;
                  (including active tuberculosis), renal, gastrointestinal, endocrine, infectious,&#xD;
                  malignancy, neurological (including auditory) and history of convulsions or other&#xD;
                  abnormality (including recent head trauma),&#xD;
&#xD;
               3. Clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain&#xD;
                  associated with jaundice) or known severe liver disease (i.e. decompensated&#xD;
                  cirrhosis, Child-Pugh stage 3 or 4)&#xD;
&#xD;
         12. Participant the Investigator considers at particular risk of receiving an&#xD;
             anti-malarial or of participating in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jang Sik Shin</last_name>
    <role>Study Director</role>
    <affiliation>Shin Poong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MRC Unit The Gambia at the London School of Hygiene and Tropical Medicine,</name>
      <address>
        <city>Fajara,</city>
        <state>Banjul,</state>
        <country>Gambia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tropical Diseases Research Centre</name>
      <address>
        <city>Ndola</city>
        <country>Zambia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Gambia</country>
    <country>Zambia</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>September 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>September 27, 2019</last_update_submitted>
  <last_update_submitted_qc>September 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asymptomatic malaria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Malaria, Falciparum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Artesunate</mesh_term>
    <mesh_term>Pyronaridine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03814616
org study id: SP-C-026-18
nct id: NCT03814616
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will assess the efficacy of Pyramax administered for three-day, two-day or one
      day, in clearing a P. falciparum infection in asymptomatic carriers.

      .
This is a randomized, open-label, three-arm, out-patient study in asymptomatic individuals
      with P. falciparum monoinfection confirmed at baseline, who are >5 years of age and >20kg
      body weight. A total of 300 participants will be randomised into the study; 100 participants
      in each of three treatment arms.

      Patients who fulfil the entry criteria (all inclusion and none of the exclusion criteria)
      will be recruited and randomized to receive Pyramax orally for three days, two days or one
      day in a randomization ratio of 1:1:1.

      All participants will be followed until Day 63 (counted from day 0) and blood samples will be
      taken on Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42 and 63 for malaria diagnostics, parasite
      density and qPCR. In addition, blood samples reverse-transcriptase (RT)-PCR will be taken on
      Days 0, 1, 2, 3, 7 and 14.

      Participants will be administered local SOC treatment if they meet any of the
      protocol-specific criteria of treatment failure: Early treatment failure, Late clinical
      failure, or Late parasitological failure up to and including Day 63, or if the participant
      withdraws at any time before Day 63, and is parasite positive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PCR-adjusted APR at Day 28 (based on slide assessment by microscopy)
time frame: Day 28
description: To assess the efficacy of each dosing regimen PCR-adjusted Adequate parasitological response (APR) at Day 28
measure: PCR-adjusted APR
time frame: 63 days
description: To assess the efficacy of each dosing regimen PCR-adjusted APR at Day 63
measure: PCR-unadjusted APR
time frame: 63 days
description: To assess the efficacy of each dosing regimen PCR-unadjusted APR at Day 63
measure: Rate of recurrent infections, recrudescence and new infections
time frame: 63 days
description: To assess the efficacy of each dosing regimen on rate of recurrent infections, recrudescence and new infections
measure: Proportion of parasite free participants
time frame: 4 days
description: Proportion of participants who are parasite free by 4-8 hours, Day 1, Day 2 and Day 3 post first dosing
measure: Gametocyte incidence
time frame: 14 days
description: The area under the curve (AUC) up to Day 14 (post first dose) of gametocytes in participants with gametocytes at baseline, and separately in participants without gametocytes at baseline
measure: Adverse Events
time frame: 63 days
description: Number (%) of patients and number of events with:
TEAEs,
serious TEAEs,
study drug related TEAEs,
study drug related serious TEAEs,
malaria-related TEAEs,
malaria-related serious TEAEs
Number (%) of patients with TEAEs and drug-related TEAEs by maximum severity, based on Grade 1 to Grade 5 (CTCAE V4.03) severity grading Adverse events will be coded by MedDRA primary system organ class and preferred term.
Hepatotoxicity related TEAEs o The number and percentage of patients with hepatotoxicity related TEAEs, based on the Standard MedDRA Query (SMQ) narrow search "Drug-related hepatic disorders" will be summarised and clinical biochemistry parameters
measure: Clinical laboratory data - Haematology
time frame: 63 days
description: Haemoglobin, haematocrit, erythrocytes, platelets, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.
measure: Clinical laboratory data - Biochemistry
time frame: 63 days
description: Total and conjugated bilirubin will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.
measure: Clinical laboratory data - Liver Enzymes
time frame: 63 days
description: Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST), Alkaline Phosphatase will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. IU/L units will be used to summarise the data
measure: Clinical laboratory data - Liver Enzyme Elevations
time frame: 63 days
description: The number (%) of participants with liver enzyme elevations after first drug administration as defined below will be summarised.
ALT or AST > 3 x Upper Limit of Normal (ULN)
ALT or AST > 5 x ULN
ALT or AST > 8 x ULN
ALT or AST > 3 x ULN and bilirubin > 2 x ULN at the same time point (when conjugated bilirubin fraction is missing)
ALT or AST > 3 x ULN and bilirubin > 2 x ULN, together with a conjugated bilirubin fraction >35% (Potential Hy's law cases), at the same time point
measure: Vital signs - Blood pressure
time frame: 63 days
description: Supine systolic and diastolic blood pressure (mm Hg) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
measure: Vital signs - Pulse rate
time frame: 63 days
description: Pulse rate (bpm) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
measure: Vital signs - Temperature
time frame: 63 days
description: Temperature (degrees Celsius) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
measure: Parasite free by qPCR quantification
time frame: 63 days
description: To estimate the proportion of participants who are parasite free by qPCR quantification.
measure: PCR-adjusted APR by qPCR
time frame: 63 days
description: To estimate PCR-adjusted APR by qPCR.To estimate PCR-unadjusted APR by qPCR. To estimate the rate of recurrent infections, recrudescences and new infections by qPCR until Day 63 (post first dose) by KM analysis.
measure: Percentage change in gametocytaemia.
time frame: 63 days
description: In participants with positive detection of gametocytes by reverse transcriptase (RT)-PCR at baseline, to evaluate percentage reduction in gametocytaemia.
measure: AUC of gametocytaemia by RT-PCR
time frame: 14 days
description: To estimate area under the curve (AUC) up to Day 14 of gametocytaemia by RT-PCR, in participants with positive RT-PCR at baseline and separately in participants with negative RT-PCR at baseline
measure: Relationship between artesunate and pyronaridine concentration and efficacy
time frame: 28 days
description: To explore the relationship between artesunate and pyronaridine concentration and efficacy (PCR-adjusted APR at Day 28, based on slide assessment by microscopy)
arm group label: Arm Pyramax 3 days
arm group type: Experimental
description: Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for three days (Arm A)
arm group label: Arm Pyramax 2 days
arm group type: Experimental
description: Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for two days (Arm B)
arm group label: Arm Pyramax 1 day
arm group type: Experimental
description: Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for one day (Arm C)
intervention type: Drug
intervention name: Pyronaridine tetraphosphate 180mg:artesunate 60mg
description: ACT
arm group label: Arm Pyramax 1 day
arm group label: Arm Pyramax 2 days
arm group label: Arm Pyramax 3 days
other name: Pyramax
criteria: 
gender: All
minimum age: 5 Years
maximum age: N/A
healthy volunteers: No
last name: Jang Sik Shin
role: Study Director
affiliation: Shin Poong
facility: 
facility: 
country: Gambia
country: Zambia
responsible party type: Sponsor
mesh term: Malaria
mesh term: Malaria, Falciparum
mesh term: Artesunate
mesh term: Pyronaridine
sharing ipd: Undecided