<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/NCT03764527</url>
  </required_header>
  <id_info>
    <org_study_id>Aco-study</org_study_id>
    <nct_id>NCT03764527</nct_id>
  </id_info>
  <brief_title>Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate + Amodiaquine in Zanzibar</brief_title>
  <acronym>AcoI</acronym>
  <official_title>Randomized Study of the Tolerability and Efficacy of Artemether-Lumefantrine Versus Artesunate Plus Amodiaquine Coadministered for the Treatment of Uncomplicated Falciparum Malaria in Zanzibar</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Professor Anders Björkman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zanzibar Malaria Control Programme</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>World Health Organization</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in&#xD;
      children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or&#xD;
      Coartem®.&#xD;
&#xD;
      Secondary objectives were to determine safety and possible selection of mutations related to&#xD;
      the resistance of the tested drugs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Combination therapy, the new strategy for malaria treatment, is based on the hypothesis that&#xD;
      two (or more) components of different mechanisms of action protect each other from&#xD;
      development of resistance. Artemisinin as well as its two derivatives, e.g. artemether and&#xD;
      artesunate, constitute a family of compounds with several attractive features for such a&#xD;
      combination, due mainly to their rapid onset of effective action against multidrug-resistant&#xD;
      P. falciparum and their gametocytocidal effect, which potentially reduces transmission of&#xD;
      resistant alleles. There also appears to be no cross-resistance with other known&#xD;
      anti-malarials. Because of the short half-life of this family of compounds, their use as&#xD;
      mono-therapy requires multiple daily doses over a period of 7 days. Combining them with&#xD;
      longer acting partner -drugs allows for a reduction in treatment duration while&#xD;
      simultaneously enhancing the efficacy and reducing the likelihood of resistance development.&#xD;
&#xD;
      As of October 2001 the following anti-malarial drugs were recommended for malaria treatment&#xD;
      in Zanzibar:&#xD;
&#xD;
        1. Artesunate (AS)+ Amodiaquine (AQ) - &quot;first line&quot; (AA)&#xD;
&#xD;
        2. Lumefantrine-artemether (Co-artem®) (CO) - &quot;second line&quot;&#xD;
&#xD;
        3. Quinine, if failure or contra indication of 1 &amp; 2, or for treatment of severe malaria&#xD;
&#xD;
        4. Sulfadoxine-pyrimethamine (SP) for Intermittent Presumptive Treatment in pregnancy (IPT)&#xD;
&#xD;
      The move that the Zanzibar Ministry of Health has taken with this new treatment&#xD;
      policy/strategy provided a unique opportunity to investigate the potential value of&#xD;
      combination therapy when introduced on a large scale. Using artemisinine derivatives in&#xD;
      combination with anti-malarials with longer half-lives is thought to be highly effective and&#xD;
      considerably prevent the development of parasite resistance to the individual drugs. This&#xD;
      study therefore provided baseline data on the efficacy of the new treatment policy and also&#xD;
      for future monitoring of the policy in Zanzibar.&#xD;
&#xD;
      All children presenting with clinical signs of malaria at the study site were considered&#xD;
      possible study subjects. The guardians of these children were informed about the study orally&#xD;
      in Swahili for providing informed consent. Those who were willing to participate in the study&#xD;
      were treated according to local standard procedure. The patient was tested for parasites&#xD;
      using light microscopy on Giemsa stained blood films. A detailed clinical history, a clinical&#xD;
      examination including an axillary temperature, was assessed. Haemoglobin was assessed and&#xD;
      blood samples were collected on filter paper for each child for genotyping of the parasites&#xD;
      as well as for determining blood levels of different antimalarial drugs.&#xD;
&#xD;
      The children included in the study were assigned to one of the two treatment options&#xD;
      according to randomisation schedule, except children &lt;9 months weighing &lt;9 kg who were&#xD;
      assigned AA because AL was registered for treatment of children &lt;9 months weighing &lt;9 kg. The&#xD;
      drugs were given in standard doses according to bodyweight: artesunate 4 mg/kg bodyweight +&#xD;
      amodiaquine 10 mg/kg bodyweight, once daily for 3 days, Coartem: 9 to &lt;15 kg: 1 tablet; 15-25&#xD;
      kg: 2 tablets, twice daily for 3 days. All drugs were administrated under direct supervision&#xD;
      of a study nurse. Full drug doses were re-administered if a patient spits out or vomits&#xD;
      within 30 minutes. Drug treatment was provided free of charge.&#xD;
&#xD;
      The guardian was asked to bring their child back to the study site on day 1, 2, 3, 7, 14, 21,&#xD;
      28, 35 and 42. If they failed to do so they were visited in their homes to assure proper&#xD;
      follow-up. At each follow-up the investigator asked about concomitant medication and adverse&#xD;
      events, carefully filling out the clinical report form (CRF). If, during the follow-up&#xD;
      between day 14 and 42, a child presented with fever, all tests and examinations were run as&#xD;
      on day 0. If the child was clinically and parasitologically diagnosed with malaria again, he&#xD;
      was treated as a new infection as of the national recommended guidelines. If diagnosed with&#xD;
      severe malaria during the follow-up period the patient was given rescue treatment (oral or&#xD;
      intravenous Quinine) and taken out of the study. Each time an enrolled child presented at the&#xD;
      site the CRF was completed with regards to clinical and laboratory status, treatment given&#xD;
      and possible adverse events.&#xD;
&#xD;
      The study drugs were obtained from the respective companies with the assistance of WHO/TDR&#xD;
      and RBM.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2002</start_date>
  <completion_date type="Actual">February 17, 2003</completion_date>
  <primary_completion_date type="Actual">February 17, 2003</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>A comparative randomised study comparing oral treatment with AQ + AS and CO of uncomplicated falciparum malaria in children.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>The AQ+AS (AA) group received their drugs under direct observation once daily for 3 days. The Coartem (CO) group received their drugs twice daily, the second (evening) dose also under supervision. Drug treatment was thus not be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine (AA) or Coartem® (CO)</measure>
    <time_frame>42 days</time_frame>
    <description>Comparing PCR adjusted parasitological cure rate (PCR-APCR) between the two treatment options up to day 42. Parasitological cure will be adjusted using PCR genotyping of msp2 marker. Recrudescence is defined as the presence of at least one matching allelic band, and reinfection as the absence of any matching allelic band on day 0 and day of recurring parasitaemia. Patients with recurrent parasitaemia having missing filter paper sample or negative PCR results will be considered uncertain with regards to PCR adjusted outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of treatment with Artesunate + Amodiaquine (AA) or Coartem® (CO): Proportion of subjects with adverse events</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of subjects with adverse events, including early vomiting and mean values of white blood cells (WBC) and neutrophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parasite clearance</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of patients with microscopy detectable parasitaemia at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gametocyte carriage</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of patients with microscopy detectable gametocytes at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever clearance</measure>
    <time_frame>42 days</time_frame>
    <description>Proportion of patients with fever at each time point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin</measure>
    <time_frame>42 days</time_frame>
    <description>Mean and individual hemoglobin values at different time points during follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Selection of mutations in P. falciparum related to the resistance of the study drugs</measure>
    <time_frame>42 days</time_frame>
    <description>Change in possible selections of mutations related to quinoline resistance. Percentage of pfcrt and pfmdr1 mutations on day 0 and day of recurrent infection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">408</enrollment>
  <condition>Plasmodium Falciparum Malaria</condition>
  <arm_group>
    <arm_group_label>Artemether-lumefantrine (AL)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One tablet of artemether-lumefantrine (Coartem®) was administered twice daily for 3 days to children with a body weight of 9 to &lt;15 kg, and 2 tablets were administered twice daily for 3 days to children with a body weight of &gt;15 to 25 kg. All doses were taken under direct observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Artesunate + Amodiaquine (AA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Artesunate + amodiaquine (ASAQ) was administered as follows: 4 mg/kg body weight of artesunate plus 10 mg/kg body weight of amodiaquine once daily for 3 days under direct observation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Artemether-lumefantrine</intervention_name>
    <description>Two doses a day for 3 days, under supervision</description>
    <arm_group_label>Artemether-lumefantrine (AL)</arm_group_label>
    <other_name>Coartem®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Coadministered Artesunate plus Amodiaquine</intervention_name>
    <description>One dose a day for 3 days, under supervision</description>
    <arm_group_label>Artesunate + Amodiaquine (AA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children age 6-59 months and body weight ≥6 kg (AQ+AS); 9-59 months and body weight ≥9&#xD;
             kg (AL)&#xD;
&#xD;
          -  Fever or history of fever in the preceding 24 hours&#xD;
&#xD;
          -  Parasitemia ≥2000 ≤200.000 parasites per µl&#xD;
&#xD;
          -  Informed consent given by the child's parent or other adult guardian&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs of severe malaria or other danger signs, such as: 1.Unconsciousness; 2. Not able&#xD;
             to sit or stand; 3.Severe anaemia (Hb ≤ 5 g/dl); 4.Convulsions; 5. Shock (systolic&#xD;
             BP&lt;50 mmHg); 6. Not able to drink or breastfeed; 7. Vomiting 3 times or more the past&#xD;
             24 hrs&#xD;
&#xD;
          -  Other diseases associated with fever&#xD;
&#xD;
          -  History of allergy to test drugs&#xD;
&#xD;
          -  History of intake of any drugs other than paracetamol and aspirin within 3 days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Abdullah Ali</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zanzibar Malaria Control Programme</affiliation>
  </overall_official>
  <results_reference>
    <citation>Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.</citation>
    <PMID>16163624</PMID>
  </results_reference>
  <results_reference>
    <citation>Sisowath C, Ferreira PE, Bustamante LY, Dahlstrom S, Martensson A, Bjorkman A, Krishna S, Gil JP. The role of pfmdr1 in Plasmodium falciparum tolerance to artemether-lumefantrine in Africa. Trop Med Int Health. 2007 Jun;12(6):736-42. doi: 10.1111/j.1365-3156.2007.01843.x.</citation>
    <PMID>17550470</PMID>
  </results_reference>
  <results_reference>
    <citation>Holmgren G, Hamrin J, Svard J, Martensson A, Gil JP, Bjorkman A. Selection of pfmdr1 mutations after amodiaquine monotherapy and amodiaquine plus artemisinin combination therapy in East Africa. Infect Genet Evol. 2007 Sep;7(5):562-9. doi: 10.1016/j.meegid.2007.03.005. Epub 2007 Mar 31.</citation>
    <PMID>17467344</PMID>
  </results_reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Professor Anders Björkman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Artemether-Lumefantrine</keyword>
  <keyword>Coartem</keyword>
  <keyword>Artesunate</keyword>
  <keyword>Amodiaquine</keyword>
  <keyword>Zanzibar</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>Lumefantrine</mesh_term>
    <mesh_term>Artemether</mesh_term>
    <mesh_term>Artemether, Lumefantrine Drug Combination</mesh_term>
    <mesh_term>Amodiaquine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03764527
org study id: Aco-study
nct id: NCT03764527
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The primary objective of the study was to determine PCR corrected cure-rates up to day 42 in
      children with uncomplicated malaria, treated with either Artesunate + Amodiaquine or
      Coartem®.

      Secondary objectives were to determine safety and possible selection of mutations related to
      the resistance of the tested drugs.
Combination therapy, the new strategy for malaria treatment, is based on the hypothesis that
      two (or more) components of different mechanisms of action protect each other from
      development of resistance. Artemisinin as well as its two derivatives, e.g. artemether and
      artesunate, constitute a family of compounds with several attractive features for such a
      combination, due mainly to their rapid onset of effective action against multidrug-resistant
      P. falciparum and their gametocytocidal effect, which potentially reduces transmission of
      resistant alleles. There also appears to be no cross-resistance with other known
      anti-malarials. Because of the short half-life of this family of compounds, their use as
      mono-therapy requires multiple daily doses over a period of 7 days. Combining them with
      longer acting partner -drugs allows for a reduction in treatment duration while
      simultaneously enhancing the efficacy and reducing the likelihood of resistance development.

      As of October 2001 the following anti-malarial drugs were recommended for malaria treatment
      in Zanzibar:

        1. Artesunate (AS)+ Amodiaquine (AQ) - "first line" (AA)

        2. Lumefantrine-artemether (Co-artem®) (CO) - "second line"

        3. Quinine, if failure or contra indication of 1 & 2, or for treatment of severe malaria

        4. Sulfadoxine-pyrimethamine (SP) for Intermittent Presumptive Treatment in pregnancy (IPT)

      The move that the Zanzibar Ministry of Health has taken with this new treatment
      policy/strategy provided a unique opportunity to investigate the potential value of
      combination therapy when introduced on a large scale. Using artemisinine derivatives in
      combination with anti-malarials with longer half-lives is thought to be highly effective and
      considerably prevent the development of parasite resistance to the individual drugs. This
      study therefore provided baseline data on the efficacy of the new treatment policy and also
      for future monitoring of the policy in Zanzibar.

      All children presenting with clinical signs of malaria at the study site were considered
      possible study subjects. The guardians of these children were informed about the study orally
      in Swahili for providing informed consent. Those who were willing to participate in the study
      were treated according to local standard procedure. The patient was tested for parasites
      using light microscopy on Giemsa stained blood films. A detailed clinical history, a clinical
      examination including an axillary temperature, was assessed. Haemoglobin was assessed and
      blood samples were collected on filter paper for each child for genotyping of the parasites
      as well as for determining blood levels of different antimalarial drugs.

      The children included in the study were assigned to one of the two treatment options
      according to randomisation schedule, except children <9 months weighing <9 kg who were
      assigned AA because AL was registered for treatment of children <9 months weighing <9 kg. The
      drugs were given in standard doses according to bodyweight: artesunate 4 mg/kg bodyweight +
      amodiaquine 10 mg/kg bodyweight, once daily for 3 days, Coartem: 9 to <15 kg: 1 tablet; 15-25
      kg: 2 tablets, twice daily for 3 days. All drugs were administrated under direct supervision
      of a study nurse. Full drug doses were re-administered if a patient spits out or vomits
      within 30 minutes. Drug treatment was provided free of charge.

      The guardian was asked to bring their child back to the study site on day 1, 2, 3, 7, 14, 21,
      28, 35 and 42. If they failed to do so they were visited in their homes to assure proper
      follow-up. At each follow-up the investigator asked about concomitant medication and adverse
      events, carefully filling out the clinical report form (CRF). If, during the follow-up
      between day 14 and 42, a child presented with fever, all tests and examinations were run as
      on day 0. If the child was clinically and parasitologically diagnosed with malaria again, he
      was treated as a new infection as of the national recommended guidelines. If diagnosed with
      severe malaria during the follow-up period the patient was given rescue treatment (oral or
      intravenous Quinine) and taken out of the study. Each time an enrolled child presented at the
      site the CRF was completed with regards to clinical and laboratory status, treatment given
      and possible adverse events.

      The study drugs were obtained from the respective companies with the assistance of WHO/TDR
      and RBM.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A comparative randomised study comparing oral treatment with AQ + AS and CO of uncomplicated falciparum malaria in children.
primary purpose: Treatment
masking: None (Open Label)
masking description: The AQ+AS (AA) group received their drugs under direct observation once daily for 3 days. The Coartem (CO) group received their drugs twice daily, the second (evening) dose also under supervision. Drug treatment was thus not be blinded.
measure: PCR corrected cure-rates up to day 42 in children with uncomplicated malaria, treated with either Artesunate + Amodiaquine (AA) or Coartem® (CO)
time frame: 42 days
description: Comparing PCR adjusted parasitological cure rate (PCR-APCR) between the two treatment options up to day 42. Parasitological cure will be adjusted using PCR genotyping of msp2 marker. Recrudescence is defined as the presence of at least one matching allelic band, and reinfection as the absence of any matching allelic band on day 0 and day of recurring parasitaemia. Patients with recurrent parasitaemia having missing filter paper sample or negative PCR results will be considered uncertain with regards to PCR adjusted outcome.
measure: Safety of treatment with Artesunate + Amodiaquine (AA) or Coartem® (CO): Proportion of subjects with adverse events
time frame: 42 days
description: Proportion of subjects with adverse events, including early vomiting and mean values of white blood cells (WBC) and neutrophils
measure: Parasite clearance
time frame: 42 days
description: Proportion of patients with microscopy detectable parasitaemia at each time point
measure: Gametocyte carriage
time frame: 42 days
description: Proportion of patients with microscopy detectable gametocytes at each time point
measure: Fever clearance
time frame: 42 days
description: Proportion of patients with fever at each time point
measure: Hemoglobin
time frame: 42 days
description: Mean and individual hemoglobin values at different time points during follow up
measure: Selection of mutations in P. falciparum related to the resistance of the study drugs
time frame: 42 days
description: Change in possible selections of mutations related to quinoline resistance. Percentage of pfcrt and pfmdr1 mutations on day 0 and day of recurrent infection.
arm group label: Artemether-lumefantrine (AL)
arm group type: Active Comparator
description: One tablet of artemether-lumefantrine (Coartem®) was administered twice daily for 3 days to children with a body weight of 9 to <15 kg, and 2 tablets were administered twice daily for 3 days to children with a body weight of >15 to 25 kg. All doses were taken under direct observation.
arm group label: Artesunate + Amodiaquine (AA)
arm group type: Active Comparator
description: Artesunate + amodiaquine (ASAQ) was administered as follows: 4 mg/kg body weight of artesunate plus 10 mg/kg body weight of amodiaquine once daily for 3 days under direct observation.
intervention type: Drug
intervention name: Artemether-lumefantrine
description: Two doses a day for 3 days, under supervision
arm group label: Artemether-lumefantrine (AL)
other name: Coartem®
intervention type: Drug
intervention name: Coadministered Artesunate plus Amodiaquine
description: One dose a day for 3 days, under supervision
arm group label: Artesunate + Amodiaquine (AA)
criteria: 
gender: All
minimum age: 6 Months
maximum age: 59 Months
last name: Abdullah Ali
role: Principal Investigator
affiliation: Zanzibar Malaria Control Programme
citation: Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.
PMID: 16163624
citation: Sisowath C, Ferreira PE, Bustamante LY, Dahlstrom S, Martensson A, Bjorkman A, Krishna S, Gil JP. The role of pfmdr1 in Plasmodium falciparum tolerance to artemether-lumefantrine in Africa. Trop Med Int Health. 2007 Jun;12(6):736-42. doi: 10.1111/j.1365-3156.2007.01843.x.
PMID: 17550470
citation: Holmgren G, Hamrin J, Svard J, Martensson A, Gil JP, Bjorkman A. Selection of pfmdr1 mutations after amodiaquine monotherapy and amodiaquine plus artemisinin combination therapy in East Africa. Infect Genet Evol. 2007 Sep;7(5):562-9. doi: 10.1016/j.meegid.2007.03.005. Epub 2007 Mar 31.
PMID: 17467344
responsible party type: Sponsor-Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Professor Anders Björkman
investigator title: Professor
mesh term: Malaria
mesh term: Malaria, Falciparum
mesh term: Artesunate
mesh term: Lumefantrine
mesh term: Artemether
mesh term: Artemether, Lumefantrine Drug Combination
mesh term: Amodiaquine