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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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7 June 2021 |
Main ID: |
NCT03338244 |
Date of registration:
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07/11/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
MORDORIIMortY5 |
Scientific title:
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Mortality Reduction After Oral Azithromycin Contingency: Mortality Study |
Date of first enrolment:
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October 20, 2017 |
Target sample size:
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113994 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT03338244 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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Niger
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United States
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Contacts
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Name:
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Tom M Lietman, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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UCSF Proctor Foundation |
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Name:
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Elodie Lebas, RN |
Address:
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Telephone:
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Email:
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Affiliation:
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UCSF Proctor Foundation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Communities- All communities eligible for MORDOR (NCT02047981)
- Individuals-All children aged 1-60 months (up to but not including the 5th birthday),
as assessed via biannual census
Exclusion Criteria:
- 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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Macrolide resistance in children aged 1-60 months
[Time Frame: 18 months]
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Secondary Outcome(s)
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Campylobacter and other pathogenic organisms in stool
[Time Frame: 18 months]
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Microbial composition of stool
[Time Frame: 18 months]
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Secondary ID(s)
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10-01036-Y4
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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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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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