xml: <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/NCT05980156</url>
    </required_header>
    <id_info>
      <org_study_id>HP-00098250v3</org_study_id>
      <nct_id>NCT05980156</nct_id>
    </id_info>
    <brief_title>Comparing Chemoprevention Drugs for School-based Malaria Control</brief_title>
    <official_title>Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Maryland, Baltimore</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Kamuzu University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Doris Duke Charitable Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Maryland, Baltimore</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 is an individually randomized, controlled, single blind three arm clinical trial of&#xD;
        malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with&#xD;
        dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with&#xD;
        sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students&#xD;
        will receive standard of care (no preventive treatment). Outcomes include P. falciparum&#xD;
        infection and parasite density, anemia, cognitive function and educational testing, as well&#xD;
        as infection prevalence in young children sleeping student's households to assess the impact&#xD;
        on transmission.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Students attending a single primary school in Machinga District, Malawi who were enrolled in&#xD;
        NCT05244954 were offered enrollment in this follow-on study. The intervention will be&#xD;
        conducted every 6-weeks during the two school terms which coincide with peak malaria&#xD;
        transmission. Students in the IPT-DP arm will be treated with with&#xD;
        dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or&#xD;
        chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with&#xD;
        sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or&#xD;
        chloroquine alone (females 10 years old or older).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 13, 2023</start_date>
    <completion_date type="Actual">July 28, 2023</completion_date>
    <primary_completion_date type="Actual">July 28, 2023</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>Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Laboratory technicians processing samples will be blinded to participant's study arm.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Number of participants with P. falciparum infection</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>detected by polymerase chain reaction (PCR, binary)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of participants with anemia</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>World Health Organization age-sex definitions (binary)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean hemoglobin concentration</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>g/dL (continuous)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total parasite density</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>log transformed (continuous)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of clinical malaria</measure>
      <time_frame>through study completions, approximately 6 months</time_frame>
      <description>cumulative incidence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>P. falciparum prevalence among children less than 5 years old living in households with study participants</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>detected by PCR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>sustained attention</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>code transmission test score (continuous)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>selective attention</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>selective attention test score (continuous)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Literacy skills</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>onetest reading test score (continuous)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Math skills</measure>
      <time_frame>6-8 weeks after the last intervention</time_frame>
      <description>onetest math score (continuous)</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">646</enrollment>
    <condition>Malaria,Falciparum</condition>
    <condition>Anemia in Children</condition>
    <arm_group>
      <arm_group_label>Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Students will not receive preventive treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dihydroartemisinin-Piperaquine</intervention_name>
      <description>Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).</description>
      <arm_group_label>Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)</arm_group_label>
      <other_name>DP</other_name>
      <other_name>D-Artepp</other_name>
      <other_name>DuoCotecxin</other_name>
      <other_name>Artekin</other_name>
      <other_name>Eurartesim</other_name>
      <other_name>Ridmal</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Chloroquine</intervention_name>
      <description>Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.</description>
      <arm_group_label>Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)</arm_group_label>
      <arm_group_label>Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)</arm_group_label>
      <other_name>Aralen</other_name>
      <other_name>Hydroxychloroquine</other_name>
      <other_name>Lariago</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Sulfadoxine pyrimethamine</intervention_name>
      <description>Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).</description>
      <arm_group_label>Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)</arm_group_label>
      <other_name>SP</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Students (enrolled in the primary intervention)&#xD;
  &#xD;
            -  Previously enrolled in NCT05244954&#xD;
  &#xD;
            -  Currently enrolled in the study school&#xD;
  &#xD;
            -  Plan to attend the study school for the remainder of the school year&#xD;
  &#xD;
            -  Parent/guardian available to provide written informed consent Younger children in&#xD;
               participant households (enrolled in the Household Prevalence survey)&#xD;
  &#xD;
            -  Slept in the household for most nights in the last month&#xD;
  &#xD;
            -  Age 6-59 months&#xD;
  &#xD;
            -  Parent/guardian available to provide written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Students (enrolled in the primary intervention)&#xD;
  &#xD;
            -  Current evidence of severe malaria or danger signs&#xD;
  &#xD;
            -  Known adverse reaction to the study drugs&#xD;
  &#xD;
            -  History of cardiac problems or fainting&#xD;
  &#xD;
            -  Taking medications known to prolong QT&#xD;
  &#xD;
            -  Family history of prolonged QT&#xD;
  &#xD;
            -  Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole&#xD;
  &#xD;
            -  Epilepsy&#xD;
  &#xD;
            -  Psoriasis Household members (enrolled in the Household Prevalence survey)&#xD;
  &#xD;
            -  Household with more than one school-age child enrolled in the study&#xD;
  &#xD;
            -  Current evidence of severe malaria or danger signs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Months</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lauren Cohee, MD MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Maryland School of Medicine</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kamuzu University of Health Sciences</name>
        <address>
          <city>Blantyre</city>
          <country>Malawi</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Malawi</country>
    </location_countries>
    <reference>
      <citation>Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.</citation>
      <PMID>33767384</PMID>
    </reference>
    <reference>
      <citation>Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.</citation>
      <PMID>33222799</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
      <investigator_full_name>Lauren Cohee</investigator_full_name>
      <investigator_title>Assistant Professor of Pediatrics</investigator_title>
    </responsible_party>
    <keyword>malaria</keyword>
    <keyword>school</keyword>
    <keyword>chemoprevention</keyword>
    <keyword>preventive treatment</keyword>
    <keyword>education</keyword>
    <keyword>cognitive function</keyword>
    <keyword>adolescent</keyword>
    <keyword>hemoglobin</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>Hydroxychloroquine</mesh_term>
      <mesh_term>Chloroquine</mesh_term>
      <mesh_term>Pyrimethamine</mesh_term>
      <mesh_term>Piperaquine</mesh_term>
      <mesh_term>Sulfadoxine</mesh_term>
      <mesh_term>Fanasil, pyrimethamine drug combination</mesh_term>
      <mesh_term>Artenimol</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all individual participant data that underlie results in a publication</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>After results publication</ipd_time_frame>
      <ipd_access_criteria>Public access with registration to allow tracking</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05980156
  org study id: HP-00098250v3
  nct id: NCT05980156
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is an individually randomized, controlled, single blind three arm clinical trial of
        malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with
        dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with
        sulfadoxine-pyrimethamine (SP) plus chloroquine (CQ) (IPT-SPCQ). Arm 3: Control - students
        will receive standard of care (no preventive treatment). Outcomes include P. falciparum
        infection and parasite density, anemia, cognitive function and educational testing, as well
        as infection prevalence in young children sleeping student's households to assess the impact
        on transmission.
  Students attending a single primary school in Machinga District, Malawi who were enrolled in
        NCT05244954 were offered enrollment in this follow-on study. The intervention will be
        conducted every 6-weeks during the two school terms which coincide with peak malaria
        transmission. Students in the IPT-DP arm will be treated with with
        dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or
        chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with
        sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or
        chloroquine alone (females 10 years old or older).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Students were randomized to three arms in the original trial. In this follow-on study, students will remain in their study arms. Arm 1 which previously received intermittent screening-and-treatment will now receive intermittent preventive treatment with sulfadoxine-pyrimethamine plus chloroquine. Arm 2 which received intermittent preventive treatment with dihydroartemisinin-piperaquine will again receive intermittent preventive treatment with dihydroartemisinin-piperaquine. Arm 3 the control arm will continue as a control. Females 10 years and older (potentially post-menarche) in Arms 1 and 2 will receive chloroquine alone.
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: Laboratory technicians processing samples will be blinded to participant's study arm.
  measure: Number of participants with P. falciparum infection
  time frame: 6-8 weeks after the last intervention
  description: detected by polymerase chain reaction (PCR, binary)
  measure: Number of participants with anemia
  time frame: 6-8 weeks after the last intervention
  description: World Health Organization age-sex definitions (binary)
  measure: Mean hemoglobin concentration
  time frame: 6-8 weeks after the last intervention
  description: g/dL (continuous)
  measure: Total parasite density
  time frame: 6-8 weeks after the last intervention
  description: log transformed (continuous)
  measure: Rate of clinical malaria
  time frame: through study completions, approximately 6 months
  description: cumulative incidence
  measure: P. falciparum prevalence among children less than 5 years old living in households with study participants
  time frame: 6-8 weeks after the last intervention
  description: detected by PCR
  measure: sustained attention
  time frame: 6-8 weeks after the last intervention
  description: code transmission test score (continuous)
  measure: selective attention
  time frame: 6-8 weeks after the last intervention
  description: selective attention test score (continuous)
  measure: Literacy skills
  time frame: 6-8 weeks after the last intervention
  description: onetest reading test score (continuous)
  measure: Math skills
  time frame: 6-8 weeks after the last intervention
  description: onetest math score (continuous)
  arm group label: Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
  arm group type: Experimental
  description: All students are treated at each intervention. Treatment will be with DP (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
  arm group label: Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
  arm group type: Experimental
  description: All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
  arm group label: Control
  arm group type: No Intervention
  description: Students will not receive preventive treatment.
  intervention type: Drug
  intervention name: Dihydroartemisinin-Piperaquine
  description: Treatment will be with DP (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
  arm group label: Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
  other name: DP
  other name: D-Artepp
  other name: DuoCotecxin
  other name: Artekin
  other name: Eurartesim
  other name: Ridmal
  intervention type: Drug
  intervention name: Chloroquine
  description: Treatment of females 10 years old and older in Arm 1 and treatment of all participants in Arm 2.
  arm group label: Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
  arm group label: Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
  other name: Aralen
  other name: Hydroxychloroquine
  other name: Lariago
  intervention type: Drug
  intervention name: Sulfadoxine pyrimethamine
  description: Treatment will be with SP and chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
  arm group label: Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
  other name: SP
  criteria: 
  gender: All
  minimum age: 6 Months
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Lauren Cohee, MD MS
  role: Principal Investigator
  affiliation: University of Maryland School of Medicine
  facility: 
  country: Malawi
  citation: Cohee LM, Valim C, Coalson JE, Nyambalo A, Chilombe M, Ngwira A, Bauleni A, Seydel KB, Wilson ML, Taylor TE, Mathanga DP, Laufer MK. School-based screening and treatment may reduce P. falciparum transmission. Sci Rep. 2021 Mar 25;11(1):6905. doi: 10.1038/s41598-021-86450-5.
  PMID: 33767384
  citation: Cohee LM, Opondo C, Clarke SE, Halliday KE, Cano J, Shipper AG, Barger-Kamate B, Djimde A, Diarra S, Dokras A, Kamya MR, Lutumba P, Ly AB, Nankabirwa JI, Njagi JK, Maiga H, Maiteki-Sebuguzi C, Matangila J, Okello G, Rohner F, Roschnik N, Rouhani S, Sissoko MS, Staedke SG, Thera MA, Turner EL, Van Geertruyden JP, Zimmerman MB, Jukes MCH, Brooker SJ, Allen E, Laufer MK, Chico RM. Preventive malaria treatment among school-aged children in sub-Saharan Africa: a systematic review and meta-analyses. Lancet Glob Health. 2020 Dec;8(12):e1499-e1511. doi: 10.1016/S2214-109X(20)30325-9. Epub 2020 Oct 22.
  PMID: 33222799
  responsible party type: Principal Investigator
  investigator affiliation: University of Maryland, Baltimore
  investigator full name: Lauren Cohee
  investigator title: Assistant Professor of Pediatrics
  mesh term: Malaria
  mesh term: Malaria, Falciparum
  mesh term: Hydroxychloroquine
  mesh term: Chloroquine
  mesh term: Pyrimethamine
  mesh term: Piperaquine
  mesh term: Sulfadoxine
  mesh term: Fanasil, pyrimethamine drug combination
  mesh term: Artenimol
  sharing ipd: Yes
  ipd description: all individual participant data that underlie results in a publication
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: After results publication
  ipd access criteria: Public access with registration to allow tracking