<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/NCT03784391</url>
  </required_header>
  <id_info>
    <org_study_id>20302</org_study_id>
    <nct_id>NCT03784391</nct_id>
  </id_info>
  <brief_title>Study on Benefits of Therapy With Nifurtimox in Chagas Disease, a Parasitic Illness Mostly Transmitted to Humans by a Bug, Using Information From Patient Medical Records in Argentina</brief_title>
  <official_title>Effectiveness of Nifurtimox in Patients With Chagas' Disease Based on Data From Patient Medical Records in Argentina: a Retrospective Medical Chart Review Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <has_dmc>No</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>
      The researchers in this trial want to analyze prerecorded patient data which provide&#xD;
      information on benefits of the drug nifurtimox in patients with a sudden (acute) and long&#xD;
      lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans&#xD;
      by a bug. They also want to learn how often organs, especially the heart, are affected by the&#xD;
      illness in treated and untreated chronic Chaga's patients. In order to find this out medical&#xD;
      records of adult and pediatric patients in Argentina will be analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">April 6, 2020</completion_date>
  <primary_completion_date type="Actual">April 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Parasitological cure of adult patients with chronic Chagas' disease</measure>
    <time_frame>Retrospective analysis from late 1960s to about 1980</time_frame>
    <description>Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline.&#xD;
Adults are defined as patients who were 18 years or older at the time of initial diagnosis of acute or chronic Chagas' disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parasitological cure of pediatric patients with acute and chronic Chagas' disease</measure>
    <time_frame>Retrospective analysis from late 1960s to about 1980</time_frame>
    <description>Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline.&#xD;
Pediatric population will comprise patients aged 0 to below 18 years at the time of initial diagnosis of acute or chronic Chagas' disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of cardiac manifestations in patients with chronic Chagas' disease</measure>
    <time_frame>Retrospective analysis from late 1960s to about 1980</time_frame>
    <description>Change from a lower to a more advanced Kuschnir group or cardiac death (change of clinical group) and appearance of new abnormalities on ECG compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment of Cardiomyopathy and/or Heart Failure</measure>
    <time_frame>Retrospective analysis from late 1960s to about 1980</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">3000</enrollment>
  <condition>Chagas' Disease</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <description>Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference</arm_group_label>
    <description>Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lampit (Nifurtimox, BAYA2502)</intervention_name>
    <description>Nifurtimox is a drug already approved in some South American countries since more than 45 years</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will comprise adult and pediatric patients diagnosed with Chagas'&#xD;
        disease, respectively, who were treated with nifurtimox (nifurtimox groups). An untreated&#xD;
        reference group comprising adult patients diagnosed with chronic Chagas' disease, who did&#xD;
        not receive antitrypanosomal treatment will be considered.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged ≥0 years at time of diagnosis with Chagas' disease&#xD;
&#xD;
          -  Diagnosis of Chagas' disease confirmed by parasitological and/or serological method(s)&#xD;
             before start of antitrypanosomal treatment or during the course of this&#xD;
             antitrypanosomal treatment cycle for the first episode recorded.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with antitrypanosomal agent(s) other than nifurtimox, including experimental&#xD;
             investigational products for Chagas' disease or antitrypanosomal combination treatment&#xD;
&#xD;
          -  Patients with known evidence of organ manifestation of chronic Chagas' disease,&#xD;
             e.g.Chagas' disease-related cardiomyopathy/heart disease, Chagas' disease-related&#xD;
             digestive disease at time of primary diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Many locations</name>
      <address>
        <city>Multiple Locations</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chagas Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nifurtimox</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/NCT03784391
org study id: 20302
nct id: NCT03784391
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The researchers in this trial want to analyze prerecorded patient data which provide
      information on benefits of the drug nifurtimox in patients with a sudden (acute) and long
      lasting (chronic) Chagas´ disease an illness caused by parasites mostly transmitted to humans
      by a bug. They also want to learn how often organs, especially the heart, are affected by the
      illness in treated and untreated chronic Chaga's patients. In order to find this out medical
      records of adult and pediatric patients in Argentina will be analyzed.
observational model: Cohort
time perspective: Retrospective
measure: Parasitological cure of adult patients with chronic Chagas' disease
time frame: Retrospective analysis from late 1960s to about 1980
description: Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline.
Adults are defined as patients who were 18 years or older at the time of initial diagnosis of acute or chronic Chagas' disease
measure: Parasitological cure of pediatric patients with acute and chronic Chagas' disease
time frame: Retrospective analysis from late 1960s to about 1980
description: Change in the laboratory test result for Chagas' disease to negative after treatment with nifurtimox and without antitrypanosomal treatment compared to baseline.
Pediatric population will comprise patients aged 0 to below 18 years at the time of initial diagnosis of acute or chronic Chagas' disease
measure: Occurrence of cardiac manifestations in patients with chronic Chagas' disease
time frame: Retrospective analysis from late 1960s to about 1980
description: Change from a lower to a more advanced Kuschnir group or cardiac death (change of clinical group) and appearance of new abnormalities on ECG compared to baseline.
measure: Treatment of Cardiomyopathy and/or Heart Failure
time frame: Retrospective analysis from late 1960s to about 1980
arm group label: Treatment
description: Patients diagnosed with acute and chronic Chagas' disease, respectively, who were treated with nifurtimox
arm group label: Reference
description: Patients diagnosed with acute and chronic Chagas' disease, respectively, who did not receive antitrypanosomal treatment
intervention type: Drug
intervention name: Lampit (Nifurtimox, BAYA2502)
description: Nifurtimox is a drug already approved in some South American countries since more than 45 years
arm group label: Treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 0 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Argentina
url: http://clinicaltrials.bayer.com
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Chagas Disease
mesh term: Nifurtimox