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Mortality Reduction After Oral Azithromycin: Mortality Study (MORDORIMort)

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ClinicalTrials.gov Identifier: NCT02047981
Recruitment Status : Completed
First Posted : January 29, 2014
Results First Posted : January 3, 2020
Last Update Posted : September 9, 2020
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Johns Hopkins University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Childhood Mortality
Interventions Drug: Azithromycin
Drug: Placebo
Enrollment 190238
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Period Title: MORDOR Stage I Year 1-2
Started 97047 93191
Completed 87650 84474
Not Completed 9397 8717
Period Title: MORDOR Stage II Year 3
Started 37497 33294
Completed 34611 30931
Not Completed 2886 2363
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo Total
Hide Arm/Group Description

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Total of all reporting groups
Overall Number of Baseline Participants 97047 93191 190238
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age group Number Analyzed 97047 participants 93191 participants 190238 participants
1-5 months
7135
   7.4%
6870
   7.4%
14005
   7.4%
6-11 months
12777
  13.2%
12318
  13.2%
25095
  13.2%
12-23 months
18557
  19.1%
17886
  19.2%
36443
  19.2%
24-59 months
58578
  60.4%
56117
  60.2%
114695
  60.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97047 participants 93191 participants 190238 participants
Female
47901
  49.4%
46019
  49.4%
93920
  49.4%
Male
49146
  50.6%
47172
  50.6%
96318
  50.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97047 participants 93191 participants 190238 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
97047
 100.0%
93191
 100.0%
190238
 100.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97047 participants 93191 participants 190238 participants
Niger 40345 35747 76092
Malawi 39386 39534 78920
Tanzania 17316 17910 35226
Number of communities  
Measure Type: Number
Unit of measure:  Communities
Number Analyzed 97047 participants 93191 participants 190238 participants
762 750 1512
1.Primary Outcome
Title All-cause Mortality Rate in Children Aged 1-60 Months
Hide Description This is a single multi-site trial, with each country as a secondary analysis. Also, an interim analysis of efficacy and futility will be conducted according to a pre-specified plan in the Statistical Analysis Plan.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description:

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Overall Number of Participants Analyzed 97047 93191
Measure Type: Number
Unit of Measure: deaths per 1000 person-years
14.6 16.5
2.Primary Outcome
Title All-cause Mortality Rate in Children Aged 1-60 Months
Hide Description This was a pre-specified contingency study in Niger only in which all communities were treated with mass azithromycin during the third year of the study following the primary 24-month endpoint.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description:

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Overall Number of Participants Analyzed 37497 33294
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: deaths per 1000 person-years
23.3
(21.4 to 25.5)
24.0
(22.1 to 26.3)
3.Secondary Outcome
Title Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Niger Only)
Hide Description Deaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description:

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Overall Number of Participants Analyzed 40345 35747
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Deaths per 1000 person years
Injury
0.22
(0.14 to 0.36)
0.23
(0.14 to 0.38)
Malnutrition
0.39
(0.26 to 0.59)
0.42
(0.28 to 0.63)
AIDS
0.12
(0.06 to 0.23)
0.12
(0.06 to 0.24)
Measles
0.30
(0.19 to 0.46)
0.28
(0.17 to 0.45)
Meningitis
0.82
(0.63 to 1.09)
1.22
(0.96 to 1.57)
Dysentery
0.74
(0.55 to 0.98)
1.14
(0.88 to 1.47)
Diarrhea
3.01
(2.59 to 3.49)
3.60
(3.11 to 4.17)
Pertussis
0.04
(0.01 to 0.12)
0.04
(0.01 to 0.14)
Pneumonia
3.27
(2.85 to 3.75)
3.96
(3.46 to 4.53)
Malaria
5.60
(4.97 to 6.32)
7.22
(6.43 to 8.11)
Hemorrhagic fever
0.08
(0.03 to 0.17)
0.06
(0.02 to 0.16)
Other infection
4.24
(3.70 to 4.85)
5.06
(4.44 to 5.78)
Unspecified
1.43
(1.17 to 1.75)
1.81
(1.49 to 2.19)
Total
22.3
(20.9 to 23.9)
27.3
(25.5 to 29.1)
4.Secondary Outcome
Title Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death
Hide Description [Not Specified]
Time Frame 24 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children
Hide Description [Not Specified]
Time Frame 24 months
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
Hide Description At 6-monthly intervals a census of the communities was conducted, and for child deaths a verbal autopsy was performed to ascertain the cause using a standardized diagnostic classification. Mortality due to pneumonia or diarrhea by age group and arm are shown in the outcome measure data table below.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description:

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Overall Number of Participants Analyzed 17316 17910
Measure Type: Number
Unit of Measure: deaths per 100 person-years
Age group Mortality: 1- 5 months 0.46 0.90
Age group Mortality: 6- 11 months 0.47 0.56
Age group Mortality: 12 - 23 months 0.29 0.29
Age group Mortality: 24 - 59 months 0.15 0.10
7.Secondary Outcome
Title Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Malawi Only)
Hide Description Cause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description:

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Overall Number of Participants Analyzed 39386 39534
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: deaths per 1000 person-years
Pneumonia
1.15
(0.92 to 1.44)
1.40
(1.15 to 1.72)
Malaria
3.68
(3.25 to 4.17)
3.84
(3.40 to 4.34)
HIV/AIDS
1.06
(0.84 to 1.34)
1.54
(1.27 to 1.87)
Diarrhoea
0.67
(0.50 to 0.90)
0.72
(0.54 to 0.95)
Time Frame 36 months.
Adverse Event Reporting Description

A SAE is any adverse event that:

  • Results in death
  • Is life-threatening (i.e., causes an immediate risk of death)
  • Requires inpatient hospitalization or prolongation of existing hospitalization
  • Results in persistent or significant disability or incapacity
  • Results in a congenital anomaly or birth defect

Or that is considered to be:

· An important medical event

SAE reporting excludes mortality as measured for the primary outcome.

 
Arm/Group Title Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Hide Arm/Group Description

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to 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 for 2 years.

In Niger during year 3, all communities will be offered azithroymcin.

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 for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

Comparison of childhood mortality in communities randomized to azithromycin versus communities randomized to placebo.

Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years

In Niger during year 3, all communities will be offered azithroymcin.

Placebo: Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.

All-Cause Mortality
Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3262/97047 (3.36%)      3392/93191 (3.64%)    
Hide Serious Adverse Events
Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3273/97047 (3.37%)      3400/93191 (3.65%)    
Gastrointestinal disorders     
Suspected ileus   1/97047 (0.00%)  1 0/93191 (0.00%)  0
Diarrhea   0/97047 (0.00%)  0 1/93191 (0.00%)  1
General disorders     
Suspected dehydration   0/97047 (0.00%)  0 2/93191 (0.00%)  2
Coma   1/97047 (0.00%)  1 0/93191 (0.00%)  0
   4/97047 (0.00%)  4 0/93191 (0.00%)  0
Death   3262/97047 (3.36%)  3262 3392/93191 (3.64%)  3392
Infections and infestations     
Malaria   4/97047 (0.00%)  4 3/93191 (0.00%)  3
Respiratory, thoracic and mediastinal disorders     
ARI   0/97047 (0.00%)  0 2/93191 (0.00%)  2
Pneumonia   1/97047 (0.00%)  1 0/93191 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Biannual Mass Oral Azithromycin Biannual Mass Oral Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/97047 (0.00%)      0/93191 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ying Lin
Organization: UCSF F.I. Proctor Foundation
Phone: 4155144709
EMail: ying.lin@ucsf.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02047981    
Other Study ID Numbers: OPP1032340-A
First Submitted: January 24, 2014
First Posted: January 29, 2014
Results First Submitted: August 29, 2019
Results First Posted: January 3, 2020
Last Update Posted: September 9, 2020