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| ID | Type | Description | Link |
|---|---|---|---|
| OPP1032340-A | Other Grant/Funding Number | The Bill and Melinda Gates Foundation |
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| Name | Class |
|---|---|
| The Carter Center | OTHER |
| Bill and Melinda Gates Foundation | OTHER |
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MORDOR was a cluster-randomized placebo controlled trial that assessed the efficacy of mass azithromycin distributions for the prevention of childhood mortality. All communities were subsequently treated with mass azithromycin for one year. The present trial re-randomized communities to azithromycin or placebo for the fourth and fifth year of the study.
Pre-trial treatments: in the original MORDOR trial, communities were randomized to 4 rounds of biannual mass distributions of either azithromycin or placebo (i.e, the first two years of the trial). All communities were subsequently treated with 2 rounds of biannual mass azithromycin (i.e., the fifth and sixth rounds, during the third year of the trial).
Present trial design: The present trial enrolls all communities previously enrolled in the Niger site of MORDOR, and re-randomizes communities to biannual mass distributions of either azithromycin or placebo (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration since randomization for the original MORDOR trial, occurring in the fourth and fifth year since randomization). This results in four patterns of community-based treatment: four years of azithromycin (AAAAA), three years of azithromycin followed by one year of placebo (AAAPP), two years of placebo followed by two years of azithromycin (PPAAA), and two years of placebo followed by one year of azithromycin and then one year of placebo (PPAPP). The primary outcome will be all-cause mortality in children aged 1-59 months,as determined by biannual census. The mortality rate following re-randomization (i.e., the seventh, eighth, ninth and tenth rounds of mass drug administration) will be compared between the two re-randomized groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithro | Active Comparator | Communities will receive four rounds of biannual mass azithromycin. |
|
| Placebo | Placebo Comparator | Communities will receive four rounds of biannual mass placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality Rate in Children Aged 1-60 Months | as measured by presence on census and absence on sequential census due to death | 24 months |
| Macrolide Resistance in Children Aged 1-60 Months | as measured by nasopharyngeal swabs | 18 months |
| Normalized Macrolide Resistance in Children Aged 1-60 Months | as measured by rectal swabs. Fraction of macrolide resistance from stool specimens in children 1-60 months (core). For Niger, this includes RNA, DNA, and TAC-card methods (a binary outcome at the individual level). | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Microbial Composition of Stool | as measured by Meta-genomic Deep Sequencing | 18 months |
| Campylobacter and Other Pathogenic Organisms in Stool | as measured by molecular techniques |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tom M Lietman, MD | UCSF Proctor Foundation | Principal Investigator |
| Elodie Lebas, RN | UCSF Proctor Foundation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Proctor Foundation | San Francisco | California | 94143-0944 | United States | ||
| The Carter Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Azithro | Communities will receive four rounds of biannual mass azithromycin. Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months |
| FG001 | Placebo | Communities will receive four rounds of biannual mass placebo. Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithro | Communities will receive four rounds of biannual mass azithromycin. Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | All-cause Mortality Rate in Children Aged 1-60 Months | as measured by presence on census and absence on sequential census due to death | Number of participants at the start of MORDOR III | Posted | Number | 95% Confidence Interval | deaths per 1000 person years | 24 months |
|
2 years
No adverse events were reported other than death
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Azithro | Communities will receive four rounds of biannual mass azithromycin. Azithromycin: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Lietman | UC San Francisco - Proctor Foundation | (415) 476-1442 | tom.lietman@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 1, 2019 | Mar 23, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 1, 2020 | Mar 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| Placebo | Drug | Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months |
|
| 18 months |
| Niamey |
| Niger |
Communities will receive four rounds of biannual mass placebo. Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
|
| Primary | Macrolide Resistance in Children Aged 1-60 Months | as measured by nasopharyngeal swabs | We did collect nasopharyngeal swabs but pooling and DNA-seq that works with rectal samples was not sensitive enough for NP samples. So we have to wait for technology to catch up to be able to report these results. | Posted | 18 months |
|
|
| Primary | Normalized Macrolide Resistance in Children Aged 1-60 Months | as measured by rectal swabs. Fraction of macrolide resistance from stool specimens in children 1-60 months (core). For Niger, this includes RNA, DNA, and TAC-card methods (a binary outcome at the individual level). | 1,004 children in total (557 from 15 placebo-treated communities and 447 from 14 azithromycin-treated communities). | Posted | Mean | 95% Confidence Interval | reads per million (rM) | 18 months |
|
|
|
| Secondary | Microbial Composition of Stool | as measured by Meta-genomic Deep Sequencing | Unfortunately, we didn't collect stool, so we won't be able to report this. | Posted | 18 months |
|
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| Secondary | Campylobacter and Other Pathogenic Organisms in Stool | as measured by molecular techniques | Unfortunately, we didn't collect stool, so we won't be able to report this. | Posted | 18 months |
|
|
| 1,493 |
| 33,173 |
| 0 |
| 33,173 |
| 0 |
| 33,173 |
| EG001 | Placebo | Communities will receive four rounds of biannual mass placebo. Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months | 1,584 | 33,055 | 0 | 33,055 | 0 | 33,055 |
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| Organic Chemicals |