Childhood MortalityPhase 4MORDORIIMortY5NCT03338244
Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
A Phase 4 study testing Azithromycin in people with Childhood Mortality, run by University of California, San Francisco at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 month to 60 months
- Conditions the study is for
- Childhood Mortality
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66,228 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Oct 2017to 31 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
UCSF Proctor Foundation
San Francisco, California, 94143-0944
About this study
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.
Read the detailed description
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.
- Conditions
- Childhood Mortality
- Being tested
- Azithromycin, Placebo
- Keywords
- Childhood mortality, Mass treatment, Azithromycin, Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months
PlaceboDrug
Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
| Study group | Role | What they receive |
|---|---|---|
| Azithro | Active comparator | Communities will receive four rounds of biannual mass azithromycin. Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Communities will receive four rounds of biannual mass placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality Rate in Children Aged 1-60 Months
as measured by presence on census and absence on sequential census due to death
Measured: 24 months
Macrolide Resistance in Children Aged 1-60 Months
as measured by nasopharyngeal swabs
Measured: 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).
Measured: 18 months
Secondary outcomes (2)
Microbial Composition of Stool
as measured by Meta-genomic Deep Sequencing
Measured: 18 months
Campylobacter and Other Pathogenic Organisms in Stool
as measured by molecular techniques
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start20 Oct 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Childhood MortalityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66,228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- The Carter Center, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Tom M Lietman, MD, Principal investigator, UCSF Proctor FoundationElodie Lebas, RN, Study director, UCSF Proctor Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338244
- Sponsor's protocol ID
- 10-01036-Y4
- Other IDs
- OPP1032340-A
- Acronym
- MORDORIIMortY5
- Status last verified
- Jul 2022
- First submitted
- 7 Nov 2017
- Last updated
- 11 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality Reduction After Oral Azithromycin Contingency: Mortality Study
- ClinicalTrials.gov ID
- NCT03338244
- Acronym / sponsor ID
- MORDORIIMortY5 / 10-01036-Y4
- Conditions
- Childhood Mortality
- Keywords
- Childhood mortality, Mass treatment, Azithromycin, Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66,228 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- The Carter Center, Bill and Melinda Gates Foundation
- Study start
- 20 Oct 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 11 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithro | Active comparator | Drug: AzithromycinCommunities will receive four rounds of biannual mass azithromycin. |
| Placebo | Placebo comparator | Drug: PlaceboCommunities will receive four rounds of biannual mass placebo. |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinAlso: ZithromaxChildren aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months | Drug | Azithro |
| PlaceboChildren aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months | Drug | Placebo |
Primary outcome
All-cause Mortality Rate in Children Aged 1-60 Months
Time frame: 24 months
as measured by presence on census and absence on sequential census due to death
Macrolide Resistance in Children Aged 1-60 Months
Time frame: 18 months
as measured by nasopharyngeal swabs
Normalized Macrolide Resistance in Children Aged 1-60 Months
Time frame: 18 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).
2 secondary outcomes
Microbial Composition of Stool
Time frame: 18 months
Campylobacter and Other Pathogenic Organisms in Stool
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom M Lietman, MD principal investigator
UCSF Proctor Foundation
Elodie Lebas, RN study director
UCSF Proctor Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin in people with Childhood Mortality, run by University of California, San Francisco at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Niger. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause Mortality Rate in Children Aged 1-60 Months (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.