<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/NCT01695304</url>
  </required_header>
  <id_info>
    <org_study_id>CDC-NCEZID-6369</org_study_id>
    <secondary_id>CDCEID10A.1</secondary_id>
    <secondary_id>2439</secondary_id>
    <nct_id>NCT01695304</nct_id>
  </id_info>
  <brief_title>Trial of Ceramic Water Filters to Reduce Cryptosporidium Infection in Kenya</brief_title>
  <official_title>Pilot Intervention Trial of Ceramic Water Filters to Reduce the Burden of Cryptosporidium in Household Drinking Water in Rural Kenya.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kenya Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centers for Disease Control and Prevention</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden&#xD;
      of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very&#xD;
      young children are given drinking water or water is used in reconstitution of their food. We&#xD;
      hypothesize that ceramic water filters will remove Cryptosporidium from drinking water&#xD;
      reducing infection in infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan&#xD;
      waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at&#xD;
      improving drinking water quality, including removal of protozoa. In a recent preliminary&#xD;
      analysis of &gt;22,000 children &lt;5 years enrolled in the Global Enterics Multi-Center Study&#xD;
      (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a&#xD;
      leading cause of diarrhea in infants across all four participating African sites. This pilot&#xD;
      is the first Cryptosporidium specific intervention trial of household ceramic water filters&#xD;
      to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>This is an intervention trial of ceramic water filters, and as such cannot be masked. The intervention participants received the CWFs during the trial and the control group after the trial was over.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Longitudinal Diarrhea Prevalence</measure>
    <time_frame>6 months</time_frame>
    <description>The primary outcome measure is the longitudinal prevalence of diarrheal disease.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Facility Visits for Diarrheal Disease</measure>
    <time_frame>6 months</time_frame>
    <description>incidence rate of health facility visits for diarrheal disease per 100 person-week of observation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">227</enrollment>
  <condition>Cryptosporidium; Diarrhea</condition>
  <condition>Cryptosporidiosis</condition>
  <condition>Communicable Diseases</condition>
  <condition>Diarrheal Disease</condition>
  <arm_group>
    <arm_group_label>Intervention Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ceramic water filter</intervention_name>
    <description>In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
    <arm_group_label>Intervention Arm</arm_group_label>
    <other_name>Cera Maji ceramic water filter</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Children 4-10 months old living in selected villages in the Asembo Health and Demographic&#xD;
        Surveillance System (HDSS) study area in Kenya whose primary caretakers consent on their&#xD;
        behalf to be visited weekly for 6 months to carry out weekly illness surveillance, and have&#xD;
        a follow up home visit one year after initial enrollment into the trial. The household in&#xD;
        which the child resides must be a consenting participant in the HDSS. As the children&#xD;
        included in the trial are infants, the child's primary caretaker will be invited to&#xD;
        participate and be administered questionnaires. Random selection will be at the compound&#xD;
        level. Only one household per compound will be eligible for selection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children 4-10 months old whose households are not active consenting participants in the&#xD;
        HDSS will not be eligible for inclusion. Only the subset of children 4-10 months old who&#xD;
        are randomly selected in the sample will be eligible for participation.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>10 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Mintz, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centers for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kemri/Cdc</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Kenya</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <results_first_submitted>September 28, 2015</results_first_submitted>
  <results_first_submitted_qc>February 1, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 22, 2017</results_first_posted>
  <last_update_submitted>February 1, 2017</last_update_submitted>
  <last_update_submitted_qc>February 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cryptosporidiosis</keyword>
  <keyword>Waterborne disease</keyword>
  <keyword>Diarrheal disease</keyword>
  <keyword>Ceramic water filters</keyword>
  <keyword>infants</keyword>
  <keyword>young children</keyword>
  <keyword>drinking water</keyword>
  <keyword>Kenya</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryptosporidiosis</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>No PII will be shared with any researcher. It is possible that researchers may request access to the clean de-identified data once closed out for all aspects of the work.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Arm</title>
          <description>Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.&#xD;
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
        <group group_id="P2">
          <title>Control Arm</title>
          <description>Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="120">2 deaths &amp; 1 drop out in the intervention group, contributed some information over the 26 weeks</participants>
                <participants group_id="P2" count="120">3 deaths &amp; 2 drop out in the intervention group, contributed some information over the 26 weeks</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention Arm</title>
          <description>Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.&#xD;
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
        <group group_id="B2">
          <title>Control Arm</title>
          <description>Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="120"/>
            <count group_id="B2" value="120"/>
            <count group_id="B3" value="240"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7" lower_limit="4" upper_limit="10"/>
                    <measurement group_id="B2" value="8" lower_limit="4" upper_limit="10"/>
                    <measurement group_id="B3" value="7.5" lower_limit="4" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="62"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Luo ethnic group</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Kenya</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Longitudinal Diarrhea Prevalence</title>
        <description>The primary outcome measure is the longitudinal prevalence of diarrheal disease.</description>
        <time_frame>6 months</time_frame>
        <population>Incidence rate per 100 person-weeks of observation</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Arm</title>
            <description>Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.&#xD;
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
          </group>
          <group group_id="O2">
            <title>Control Arm</title>
            <description>Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
          </group>
        </group_list>
        <measure>
          <title>Longitudinal Diarrhea Prevalence</title>
          <description>The primary outcome measure is the longitudinal prevalence of diarrheal disease.</description>
          <population>Incidence rate per 100 person-weeks of observation</population>
          <units>Incidence rate per 100 person-weeks</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6"/>
                    <measurement group_id="O2" value="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Health Facility Visits for Diarrheal Disease</title>
        <description>incidence rate of health facility visits for diarrheal disease per 100 person-week of observation</description>
        <time_frame>6 months</time_frame>
        <population>incidence rate of health facility visits for diarrheal disease per 100 person-week of observation</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Intervention group who received ceramic water filters</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Control Group who did not receive ceramic water filters (until after the trial ended)</description>
          </group>
        </group_list>
        <measure>
          <title>Health Facility Visits for Diarrheal Disease</title>
          <description>incidence rate of health facility visits for diarrheal disease per 100 person-week of observation</description>
          <population>incidence rate of health facility visits for diarrheal disease per 100 person-week of observation</population>
          <units>incidence rate per 100 person-weeks</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2"/>
                    <measurement group_id="O2" value="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention Arm</title>
          <description>Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.&#xD;
Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
        <group group_id="E2">
          <title>Control Arm</title>
          <description>Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="120"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="120"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="120"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ciara O'Reilly, PhD</name_or_title>
      <organization>Centers for Disease Control and Prevention</organization>
      <phone>404-639-1953</phone>
      <email>bwf1@cdc.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01695304
org study id: CDC-NCEZID-6369
secondary id: CDCEID10A.1
secondary id: 2439
nct id: NCT01695304
lead sponsor: 
collaborator: 
has dmc: No
The aim of the study is to examine the efficacy of ceramic water filters to reduce the burden
      of waterborne diarrheal illness among infants in selected villages in Kenya. In Kenya very
      young children are given drinking water or water is used in reconstitution of their food. We
      hypothesize that ceramic water filters will remove Cryptosporidium from drinking water
      reducing infection in infants.
Diarrhea is a major cause of illness among children in Africa. Cryptosporidium is a protozoan
      waterborne diarrheal pathogen resistant to chlorine. Ceramic filters are effective at
      improving drinking water quality, including removal of protozoa. In a recent preliminary
      analysis of >22,000 children <5 years enrolled in the Global Enterics Multi-Center Study
      (GEMS) case-control study of moderate-to-severe diarrhea, Cryptosporidium was identified as a
      leading cause of diarrhea in infants across all four participating African sites. This pilot
      is the first Cryptosporidium specific intervention trial of household ceramic water filters
      to reduce the burden of cryptosporidiosis acquired through drinking water in rural Kenya.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
masking description: This is an intervention trial of ceramic water filters, and as such cannot be masked. The intervention participants received the CWFs during the trial and the control group after the trial was over.
measure: Longitudinal Diarrhea Prevalence
time frame: 6 months
description: The primary outcome measure is the longitudinal prevalence of diarrheal disease.
measure: Health Facility Visits for Diarrheal Disease
time frame: 6 months
description: incidence rate of health facility visits for diarrheal disease per 100 person-week of observation
arm group label: Intervention Arm
arm group type: Experimental
description: Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.
arm group label: Control Arm
arm group type: No Intervention
description: Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
intervention type: Other
intervention name: Ceramic water filter
description: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
arm group label: Intervention Arm
other name: Cera Maji ceramic water filter
criteria: 
gender: All
minimum age: 4 Months
maximum age: 10 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Eric Mintz, MD, MPH
role: Principal Investigator
affiliation: Centers for Disease Control and Prevention
facility: 
country: Kenya
responsible party type: Sponsor
mesh term: Cryptosporidiosis
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Diarrhea
sharing ipd: Yes
ipd description: No PII will be shared with any researcher. It is possible that researchers may request access to the clean de-identified data once closed out for all aspects of the work.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 