Mortality Reduction After Oral Azithromycin: Mortality Study (MORDORIMort)

• ClinicalTrials.gov Identifier: NCT02047981
• Recruitment Status: Completed
• First Posted: January 29, 2014
• Results First Posted: January 3, 2020
• Last Update Posted: November 8, 2022
• Sponsor: University of California, San Francisco
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

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

Baseline Characteristics

Arm/Group Title		Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo	Total
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
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

Outcome Measures

1. Primary Outcome

Title	All-cause Mortality Rate in Children Aged 1-60 Months
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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)
Description	Deaths were assessed via biannual population census. A pre-specified outcome was cause of death, assessed by verbal autopsy.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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
Description	Cost-effectiveness of Mass Azithromycin Administration, Per Averted Childhood Death during the 24 month phase
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

all children 1-59 months treated

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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	32369	32370
Mean (95% Confidence Interval); Unit of Measure: usd per death averted
	853; (581 to 1719)	0; (0 to 0)

5. Secondary Outcome

Title	All-cause and Cause-specific Health Clinic Visits in 1-60 Month-old Children
Description	We recorded clinic visits one year prior the study and during the first year of the study and collected outcomes of these visit.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

Number of children visiting health centers

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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	12875	12809
Measure Type: Number; Unit of Measure: post-treatment clinical visits
	5229	7647

6. Secondary Outcome

Title	Cause-specific Mortality Rate in Children Aged 1-60 Months, as Assessed From Verbal Autopsy (Tanzania Only)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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)
Description	Cause-specific mortality by intention-to-treat for the four main inferred causes of death in the study area.
Time Frame	24 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Biannual Mass Oral Azithromycin	Biannual Mass Oral Placebo
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)

Adverse Events

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
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%)
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
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• 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):

Pickering H, Hart JD, Burr S, Stabler R, Maleta K, Kalua K, Bailey RL, Holland MJ. Impact of azithromycin mass drug administration on the antibiotic-resistant gut microbiome in children: a randomized, controlled trial. Gut Pathog. 2022 Jan 6;14(1):5. doi: 10.1186/s13099-021-00478-6.

Arzika AM, Maliki R, Abdou A, Mankara AK, Harouna AN, Cook C, Hinterwirth A, Worden L, Zhong L, Chen C, Ruder K, Zhou Z, Lebas E, O'Brien KS, Oldenburg CE, Le V, Arnold BF, Porco TC, Keenan JD, Lietman TM, Doan T. Gut Resistome of Preschool Children After Prolonged Mass Azithromycin Distribution: A Cluster-randomized Trial. Clin Infect Dis. 2021 Oct 5;73(7):1292-1295. doi: 10.1093/cid/ciab485.

Doan T, Worden L, Hinterwirth A, Arzika AM, Maliki R, Abdou A, Zhong L, Chen C, Cook C, Lebas E, O'Brien KS, Oldenburg CE, Chow ED, Porco TC, Lipsitch M, Keenan JD, Lietman TM. Macrolide and Nonmacrolide Resistance with Mass Azithromycin Distribution. N Engl J Med. 2020 Nov 12;383(20):1941-1950. doi: 10.1056/NEJMoa2002606.

O'Brien KS, Arzika AM, Maliki R, Manzo F, Mamkara AK, Lebas E, Cook C, Bailey RL, West SK, Oldenburg CE, Porco TC, Arnold B, Keenan JD, Lietman TM; MORDOR Study Group. Biannual azithromycin distribution and child mortality among malnourished children: A subgroup analysis of the MORDOR cluster-randomized trial in Niger. PLoS Med. 2020 Sep 15;17(9):e1003285. doi: 10.1371/journal.pmed.1003285. eCollection 2020 Sep.

Doan T, Hinterwirth A, Arzika AM, Worden L, Chen C, Zhong L, Oldenburg CE, Keenan JD, Lietman TM. Reduction of Coronavirus Burden With Mass Azithromycin Distribution. Clin Infect Dis. 2020 Nov 19;71(16):2282-2284. doi: 10.1093/cid/ciaa606.

Keenan JD, Arzika AM, Maliki R, Elh Adamou S, Ibrahim F, Kiemago M, Galo NF, Lebas E, Cook C, Vanderschelden B, Bailey RL, West SK, Porco TC, Lietman TM; MORDOR-Niger Study Group. Cause-specific mortality of children younger than 5 years in communities receiving biannual mass azithromycin treatment in Niger: verbal autopsy results from a cluster-randomised controlled trial. Lancet Glob Health. 2020 Feb;8(2):e288-e295. doi: 10.1016/S2214-109X(19)30540-6.

Bloch EM, Munoz B, Mrango Z, Weaver J, Mboera LEG, Lietman TM, Sullivan DJ Jr, West SK. The impact on malaria of biannual treatment with azithromycin in children age less than 5 years: a prospective study. Malar J. 2019 Aug 23;18(1):284. doi: 10.1186/s12936-019-2914-8.

Doan T, Arzika AM, Hinterwirth A, Maliki R, Zhong L, Cummings S, Sarkar S, Chen C, Porco TC, Keenan JD, Lietman TM; MORDOR Study Group. Macrolide Resistance in MORDOR I - A Cluster-Randomized Trial in Niger. N Engl J Med. 2019 Jun 6;380(23):2271-2273. doi: 10.1056/NEJMc1901535. No abstract available.

Keenan JD, Arzika AM, Maliki R, Boubacar N, Elh Adamou S, Moussa Ali M, Cook C, Lebas E, Lin Y, Ray KJ, O'Brien KS, Doan T, Oldenburg CE, Callahan EK, Emerson PM, Porco TC, Lietman TM. Longer-Term Assessment of Azithromycin for Reducing Childhood Mortality in Africa. N Engl J Med. 2019 Jun 6;380(23):2207-2214. doi: 10.1056/NEJMoa1817213.

Porco TC, Hart J, Arzika AM, Weaver J, Kalua K, Mrango Z, Cotter SY, Stoller NE, O'Brien KS, Fry DM, Vanderschelden B, Oldenburg CE, West SK, Bailey RL, Keenan JD, Lietman TM; Macrolides Oraux pour Reduire les Deces avec un Oeil sur la Resistance (MORDOR) Study Group. Mass Oral Azithromycin for Childhood Mortality: Timing of Death After Distribution in the MORDOR Trial. Clin Infect Dis. 2019 May 30;68(12):2114-2116. doi: 10.1093/cid/ciy973.

Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474.

Porco TC, Stoller NE, Keenan JD, Bailey RL, Lietman TM. Public key cryptography for quality assurance in randomization for clinical trials. Contemp Clin Trials. 2015 May;42:167-8. doi: 10.1016/j.cct.2015.03.016. Epub 2015 Apr 7. No abstract available.

• 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: November 8, 2022