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Community Health Azithromycin Trial in Burkina Faso (CHAT)

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ClinicalTrials.gov Identifier: NCT03676764
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : December 20, 2019
Sponsor:
Collaborators:
Centre de Recherche en Sante de Nouna, Burkina Faso
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

An estimated 7.7 million pre-school aged children die each year, the majority from infectious diseases. Mass azithromycin distributions for trachoma may have the unintended benefit of reducing childhood mortality. We recently demonstrated the biannual mass azithromycin distribution significantly reduces all-cause child mortality in a cluster randomized trial (MORDOR I) conducted in three diverse regions of Sub-Saharan Africa.

Our long-term goal is to more precisely define the role of mass azithromycin treatments as an intervention for reducing childhood morbidity and mortality. We propose a cluster randomized trial designed to repeat the original study to confirm the original results in a different geographic study with similarly high child mortality, and to better understand the mechanism behind any effect of azithromycin on child mortality. We hypothesize that biannual mass azithromycin distribution will reduce child mortality compared to placebo, and that this effect will be primarily driven by a reduction in infectious burden.

Objectives:

  1. Determine the efficacy of biannual mass azithromycin distribution versus placebo in children aged 1-59 months for reduction in all-cause mortality.
  2. Determine the efficacy of targeted azithromycin distribution to infants during an early infant healthcare visit (approximately 5th through 12th week of life) on infant mortality.
  3. Determine the mechanism behind the effect of biannual mass azithromycin distribution for reduction in child mortality.

The study will be conducted in the Nouna District in northwestern Burkina Faso.


Condition or disease Intervention/treatment Phase
Childhood Mortality Drug: Azithromycin Drug: Placebos Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 447780 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: All eligible communities in Nouna District will be randomized in a 1:1 fashion to biannual azithromycin or placebo. Targeted treatment (vaccine visit) will be randomized 1:1 individually to azithromycin or placebo. Randomization will be conducted by T. Porco. Procedural and algorithmic details are provided in an appendix to the Statistical Analysis Plan.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The trial sites will be masked to outcomes, so the responsibility for monitoring interim analysis will fall on the DSMC
Primary Purpose: Prevention
Official Title: Community Health Azithromycin Trial in Burkina Faso
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Biannual mass oral azithromycin
Bi-annual Mass Azithromycin distribution to all children 1-60 months old in participating communities
Drug: Azithromycin
biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit

Placebo Comparator: Biannual mass oral placebo
Bi-annual Mass Placebo distribution to all children 1-60 months old in participating communities
Drug: Azithromycin
biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit

Drug: Placebos
biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit

Placebo Comparator: Targeted oral placebo
Targeted placebo to children 5 to 12 weeks old at vaccine visit or other healthy child visit
Drug: Placebos
biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit

Active Comparator: Targeted oral azithromycin
Targeted azithromycin to children 5 to 12 weeks old at vaccine visit or other healthy child visit
Drug: Azithromycin
biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit




Primary Outcome Measures :
  1. All-cause Mortality Rate in children aged 1-59 months [ Time Frame: 36 months ]
    All-cause mortality as determined by biannual census among children aged 1-59 months

  2. All-cause Mortality Rate in individually randomized children at 4-12 weeks of age [ Time Frame: 6 months ]
    All-cause mortality as determined by a follow-up visit for individually randomized children at healthy child visits


Secondary Outcome Measures :
  1. Malaria parasitemia in children 1-59 months at 36 months [ Time Frame: 36 months ]
    Malaria parasitemia as measured by thin and thick smears in a random sample of children at 36 months

  2. Weight-for-height Z-score in children 1-59 months at 36 months [ Time Frame: 36 months ]
    Weight-for-height Z-score in children 1-59 months at 36 months

  3. Height-for-age Z-score in children 1-59 months at 36 months [ Time Frame: 36 months ]
    Height-for-age Z-score in children 1-59 months at 36 months

  4. Mid-upper arm circumference in children 1-59 months at 36 months [ Time Frame: 36 months ]
    Mid-upper arm circumference in children 1-59 months at 36 months

  5. Hemoglobin concentration in children 1-59 months at 36 months [ Time Frame: 36 months ]
    Hemoglobin concentration in children 1-59 months at 36 months

  6. Nasopharyngeal macrolide resistance in children aged 1-59 months at 36 months [ Time Frame: 36 months ]
    Nasopharyngeal macrolide resistance in children aged 1-59 months at 36 months

  7. Rates of hospitalizations among children aged 1-59 months [ Time Frame: 36 months ]
    Measured via passive surveillance of clinics in study catchment area

  8. Carriage of S. pneumoniae in nasopharyngeal samples in children aged 1-59 months [ Time Frame: 36 months ]
  9. Rates of diarrhea-related clinic visits among children aged 1-59 months [ Time Frame: 36 months ]
    Measured via passive surveillance of clinics in study catchment area

  10. Rates of malaria-related clinic visits among children aged 1-59 months [ Time Frame: 36 months ]
    Measured via passive surveillance of clinics in study catchment area

  11. Rates of respiratory infection-related clinic visits among children aged 1-59 months [ Time Frame: 36 months ]
    Measured via passive surveillance of clinics in study catchment area

  12. Proportion of E. coli isolates resistant to macrolides and to antibiotics commonly used to treat pediatric infection among children aged 1-59 months at 36 months [ Time Frame: 36 months ]
    Proportion of E. coli isolates resistant to macrolides and to antibiotics commonly used to treat pediatric infection among children aged 1-59 months at 36 months

  13. Microbial diversity in the nasopharyngeal microbiome of children aged 1-59 months as measured by next generation sequencing [ Time Frame: 36 months ]
    Simpson's diversity

  14. Microbial diversity in the intestinal microbiome of children aged 1-59 months as measured by next generation sequencing at 36 months [ Time Frame: 36 months ]
    Simpson's diversity

  15. MSP-1 seropositivity among children aged 1-59 months [ Time Frame: 36 months ]
  16. Weight-for-height Z-score in individually randomized children at healthy child visits [ Time Frame: 6 months ]
  17. Height-for-age Z-score in individually randomized children at healthy child visits [ Time Frame: 6 months ]
  18. Mid-upper arm circumference in individually randomized children at healthy child visits [ Time Frame: 6 months ]
  19. Linear growth in individually randomized children [ Time Frame: 6 months ]
    Change in length from baseline to 6 months

  20. Weight gain in individually randomized children [ Time Frame: 6 months ]
    Change in weight from baseline to 6 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Month to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Communities:

Inclusion Criteria:

  • The community location in target district.
  • The community leader consents to participation in the trial (this does not obviate the need for individual consent, but without overall leadership consent, the community as a whole cannot be part of the trial).
  • Eligible communities estimated population of between 200-2,000 people
  • The community is not in an urban area

Exclusion criteria:

- Refusal of village chief

Individuals:

Inclusion Criteria

  • All children in the study communities aged 5 to 12 weeks old at the time of the vaccination visit are eligible to participate
  • Ability to feed orally
  • Appropriate consent from at least one caregiver
  • Family intends to stay within the study area

Exclusion Criteria:

  • Individuals allergic to macrolides or azalides will not be given the study antibiotic azithromycin, but will be included in the outcome
  • Refusal of parent or guardian
  • Child unable to orally feed
  • Family planning to move
  • Children younger than 28 days old or older than 12 weeks
  • Children in the bi annual drug administration group who weight less than 3.8kg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676764


Contacts
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Contact: Tom M Lietman, MD 415-502-2662 tom.lietman@ucsf.edu
Contact: Elodie J Lebas, RN 415-502-3192 elodie.lebas@ucsf.edu

Locations
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Burkina Faso
Centre de Recherche en Sante de Nouna Recruiting
Nouna, Burkina Faso
Contact: Ali Sie, MD, PhD         
Sponsors and Collaborators
University of California, San Francisco
Centre de Recherche en Sante de Nouna, Burkina Faso
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Catherine E Oldenburg, PhD University of California, San Francisco
Principal Investigator: Tom M Lietman, MD University of California, San Francisco
Principal Investigator: Ali Sie, MD, PhD Centre de Recherche en Sante de Nouna, Burkina Faso
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03676764    
Other Study ID Numbers: OPP1187628-A
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be available as per the Bill and Melinda Gates open access policy. Community based data will be available that underline the reported results (texts, tables, figures, and appendices). The study protocol and statistical analysis plan will also be made available. The data will be available following publication in accordance with the BMGF guidelines
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: december 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, San Francisco:
Childhood mortality
Azithromycin
Mass treatment
Vaccine Visit targeted treatment
Additional relevant MeSH terms:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents