A Phase 4 interventional study of Azithromycin and Placebo in Childhood Mortality, sponsored by University of California, San Francisco. Completed at 2 sites in 2 countries. Open to participants aged 1 Month to 60 Months. Per ClinicalTrials.gov, last updated 2022-08-11.
Sponsored by University of California, San Francisco · Phase 4, Interventional, and Treatment
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.
2,093 studies on the registry are indexed under Infections; 364 are open to participants now.
This study's enrollment of 66,228 is above the median of 113 across 1,304 interventional studies indexed under Infections.
Browse Infections studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
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Exclusion Criteria:
Communities will receive four rounds of biannual mass azithromycin.
Drug: Azithromycin
Communities will receive four rounds of biannual mass placebo.
Drug: Placebo
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months
Also known as: Zithromax
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
All-cause Mortality Rate in Children Aged 1-60 Months
as measured by presence on census and absence on sequential census due to death
Time frame: 24 months
Macrolide Resistance in Children Aged 1-60 Months
as measured by nasopharyngeal swabs
Time frame: 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).
Time frame: 18 months
Microbial Composition of Stool
as measured by Meta-genomic Deep Sequencing
Time frame: 18 months
Campylobacter and Other Pathogenic Organisms in Stool
as measured by molecular techniques
Time frame: 18 months
| Milestone | Azithro | Placebo |
|---|---|---|
| Started | 33173 | 33055 |
| Completed | 25995 | 25568 |
| Not completed | 7178 | 7487 |
as measured by presence on census and absence on sequential census due to death
| deaths per 1000 person years | Azithro | Placebo |
|---|---|---|
| All-cause Mortality Rate in Children Aged 1-60 Months | 24.8 (23.1 to 26.5) | 26.7 (24.5 to 28.5) |
as measured by nasopharyngeal swabs
No measurements were reported for this outcome.
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).
| reads per million (rM) | Azithro | Placebo |
|---|---|---|
| Normalized Macrolide Resistance in Children Aged 1-60 Months | 79.85 (44.31 to 124.14) | 15.79 (5.72 to 27.39) |
as measured by Meta-genomic Deep Sequencing
No measurements were reported for this outcome.
as measured by molecular techniques
No measurements were reported for this outcome.
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithro | 1,493/33,173 (4.5%) | 0/33,173 (0%) | 0/33,173 (0%) |
| Placebo | 1,584/33,055 (4.8%) | 0/33,055 (0%) | 0/33,055 (0%) |
| Age, Categorical(Participants) | Azithro | Placebo | Total |
|---|---|---|---|
| <=18 years | 33173 | 33055 | 66228 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Azithro | Placebo | Total |
|---|---|---|---|
| Female | 16052 | 16084 | 32136 |
| Male | 17121 | 16971 | 34092 |
| Race (NIH/OMB)(Participants) | Azithro | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 33173 | 33055 | 66228 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Azithro | Placebo | Total |
|---|---|---|---|
| Niger | 33173 | 33055 | 66228 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Azithromycin
University of California, San Francisco →