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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02047981 |
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Date of registration:
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24/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Mortality Reduction After Oral Azithromycin: Mortality Study
MORDORIMort |
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Scientific title:
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Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Mortality Trial |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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190238 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02047981 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Malawi
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Niger
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Tanzania
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United Kingdom
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United States
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Contacts
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Name:
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Tom M Lietman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Name:
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Catherine A Cook, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Communities
- The community location in target district.
- The community leader consents to participation in the trial
- The community's estimated population is between 200-2,000 people.
- The community is not in an urban area.
Individuals - All children aged 1-60 months (up to but not including the 5th birthday), as
assessed via biannual census.
Exclusion Criteria:
Individuals
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for
individual inclusion)
Age minimum:
1 Month
Age maximum:
60 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Childhood Mortality
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Intervention(s)
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Drug: Placebo
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Drug: Azithromycin
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Primary Outcome(s)
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All-cause Mortality Rate in Children Aged 1-60 Months
[Time Frame: 24 Months]
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All-cause Mortality Rate in Children Aged 1-60 Months
[Time Frame: 36 months]
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Secondary Outcome(s)
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All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children
[Time Frame: 24 months]
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Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
[Time Frame: 24 Months]
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Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
[Time Frame: 24 Months]
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Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death
[Time Frame: 24 months]
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Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
[Time Frame: 24 Months]
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Secondary ID(s)
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OPP1032340-A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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