<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/NCT03765931</url>
  </required_header>
  <id_info>
    <org_study_id>NCTDOXY2016</org_study_id>
    <nct_id>NCT03765931</nct_id>
  </id_info>
  <brief_title>Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment</brief_title>
  <official_title>Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Recherche pour le Developpement</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Recherche pour le Developpement</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>
      Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics&#xD;
      including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line&#xD;
      treatment with doxycycline has cured such patients. The investgators aimed to determine the&#xD;
      efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the&#xD;
      treatment of fever.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial&#xD;
      in patients aged &gt; 8 years recruited from dispensaries in the rural area of Niakhar, Senegal.&#xD;
      Participants were enrolled based on a body temperature &gt; 37.5°C, as assessed using an&#xD;
      electronic axillary thermometer. Febrile patients with a positive malaria test were excluded&#xD;
      from the study. Participants were randomly assigned (1:1) to receive either a single dose of&#xD;
      doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated&#xD;
      random number sequence. The investgators monitored participants at days 2 and 7&#xD;
      post-treatment. The primary outcome was cure after 7 days, defined as a body temperature &lt;&#xD;
      37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the&#xD;
      national ethic committees of the Senegalese Ministry of Health in May 2017&#xD;
      (0026/MSAS/DPRS/CNERS, March, 7, 2016).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up</measure>
    <time_frame>7 days follow up</time_frame>
    <description>The endpoint was cure at day-7 post-inclusion. Clinical cure was defined as a body temperature &lt; 37.5°C. Clinical failure was defined as persistence of fever &gt; 37.5°C at day-7. The investgators used a non-inferiority margin of 10%.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">274</enrollment>
  <condition>Fever</condition>
  <arm_group>
    <arm_group_label>subjects treated with doxycycline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The participants treated by doxycycline 100 mg will have one dose but followed 5 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>subjects treated with amoxycilline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Doxycycline</intervention_name>
    <description>The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged &gt; 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature &gt; 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature &lt; 37.5°C.</description>
    <arm_group_label>subjects treated with amoxycilline</arm_group_label>
    <arm_group_label>subjects treated with doxycycline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged &gt; 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature &gt; 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature &lt; 37.5°C.</description>
    <arm_group_label>subjects treated with amoxycilline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants over 8 years with no malaria fever&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Under 8 years Pregnanants women&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Niakhar observational site</name>
      <address>
        <city>Niakhar</city>
        <state>Fatick</state>
        <country>Senegal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Senegal</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>June 20, 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 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Institut de Recherche pour le Developpement</investigator_affiliation>
    <investigator_full_name>Aldiouma Diallo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fever</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Doxycycline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Will share by restitution with the communuty</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Just after close out and analysing the data</ipd_time_frame>
    <ipd_access_criteria>Share with participants but also with the ministry of heath</ipd_access_criteria>
  </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/NCT03765931
org study id: NCTDOXY2016
nct id: NCT03765931
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics
      including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line
      treatment with doxycycline has cured such patients. The investgators aimed to determine the
      efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the
      treatment of fever.
Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial
      in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal.
      Participants were enrolled based on a body temperature > 37.5°C, as assessed using an
      electronic axillary thermometer. Febrile patients with a positive malaria test were excluded
      from the study. Participants were randomly assigned (1:1) to receive either a single dose of
      doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated
      random number sequence. The investgators monitored participants at days 2 and 7
      post-treatment. The primary outcome was cure after 7 days, defined as a body temperature <
      37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the
      national ethic committees of the Senegalese Ministry of Health in May 2017
      (0026/MSAS/DPRS/CNERS, March, 7, 2016).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
primary purpose: Treatment
masking: None (Open Label)
measure: Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
time frame: 7 days follow up
description: The endpoint was cure at day-7 post-inclusion. Clinical cure was defined as a body temperature < 37.5°C. Clinical failure was defined as persistence of fever > 37.5°C at day-7. The investgators used a non-inferiority margin of 10%.
arm group label: subjects treated with doxycycline
arm group type: Active Comparator
description: The participants treated by doxycycline 100 mg will have one dose but followed 5 days
arm group label: subjects treated with amoxycilline
arm group type: Placebo Comparator
description: The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days
intervention type: Drug
intervention name: Doxycycline
description: The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
arm group label: subjects treated with amoxycilline
arm group label: subjects treated with doxycycline
intervention type: Drug
intervention name: Amoxicillin
description: The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
arm group label: subjects treated with amoxycilline
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Senegal
responsible party type: Principal Investigator
investigator affiliation: Institut de Recherche pour le Developpement
investigator full name: Aldiouma Diallo
investigator title: MD
mesh term: Fever
mesh term: Amoxicillin
mesh term: Doxycycline
sharing ipd: Yes
ipd description: Will share by restitution with the communuty
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: Just after close out and analysing the data
ipd access criteria: Share with participants but also with the ministry of heath