Trial Outcomes & Findings for MORDOR II Burkina Faso: Longitudinal Trial (NCT NCT03676751)
NCT ID: NCT03676751
Last Updated: 2023-08-09
Results Overview
The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
500 participants
Primary outcome timeframe
6 months
Results posted on
2023-08-09
Participant Flow
Participant milestones
| Measure |
Azithromycin
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
220
|
|
Overall Study
Received Allocated Treatment
|
227
|
214
|
|
Overall Study
Week 14 Follow up
|
218
|
203
|
|
Overall Study
COMPLETED
|
200
|
189
|
|
Overall Study
NOT COMPLETED
|
30
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MORDOR II Burkina Faso: Longitudinal Trial
Baseline characteristics by cohort
| Measure |
Azithromycin
n=230 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=220 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
Total
n=450 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 months
n=5 Participants
|
28 months
n=7 Participants
|
28 months
n=5 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
230 Participants
n=5 Participants
|
220 Participants
n=7 Participants
|
450 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Burkina Faso
|
230 participants
n=5 Participants
|
220 participants
n=7 Participants
|
450 participants
n=5 Participants
|
|
Mother's age
|
28 years
n=5 Participants
|
28 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Mother's education
None
|
120 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Mother's education
Primary
|
61 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Mother's education
Secondary or higher
|
49 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Mid-upper arm circumference, cm
|
14.1 cm
n=5 Participants
|
14.4 cm
n=7 Participants
|
14.3 cm
n=5 Participants
|
|
Weight, kg
|
11.2 kg
n=5 Participants
|
11.5 kg
n=7 Participants
|
11.4 kg
n=5 Participants
|
|
Height, cm
|
85.3 cm
STANDARD_DEVIATION 12.2 • n=5 Participants
|
85.4 cm
STANDARD_DEVIATION 11.8 • n=7 Participants
|
85.4 cm
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Weight-for-height Z-score
|
-0.6 score
STANDARD_DEVIATION 1.2 • n=5 Participants
|
-0.4 score
STANDARD_DEVIATION 1.1 • n=7 Participants
|
-0.5 score
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Height-for-age Z-score
|
-0.9 score
STANDARD_DEVIATION 1.3 • n=5 Participants
|
-0.8 score
STANDARD_DEVIATION 1.3 • n=7 Participants
|
-0.9 score
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Weight-for-age Z-score
|
-1.0 score
STANDARD_DEVIATION 1.1 • n=5 Participants
|
-0.7 score
STANDARD_DEVIATION 1.1 • n=7 Participants
|
-0.9 score
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Wasted (WHZ < -2)
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Stunted (HAZ < -2)
|
35 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Underweight (WAZ < -2)
|
42 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Mid-upper arm circumference < 12.5 cm
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Malaria RDT Positive
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Analysis was done 5-pooled.
The primary outcome of the study was pre-specified as α-diversity (inverse Simpson's) at the genus level, expressed in effective number. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.
Outcome measures
| Measure |
Azithromycin
n=200 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=191 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Intestinal Microbial Diversity
|
46.3 index score
Standard Deviation 9.4
|
49.5 index score
Standard Deviation 11.8
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: We were able to follow up with 221 patients in the azithromycin arm and 208 children in the placebo arm.
Presence of macrolide genetic resistance determinants measured using DNA-seq from rectal swabs from 450 children. Macrolide resistance is defined by resistance to erythromycin or clarithromycin. We compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=208 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Macrolide Resistance
|
98.89 number of reads
Standard Deviation 184.62
|
0.5 number of reads
Standard Deviation 3.24
|
SECONDARY outcome
Timeframe: 180 days post-treatmentWAZ. Weight will be measured at all follow-ups and weight-for-age z-scores will be calculated. Weight measured in kg.
Outcome measures
| Measure |
Azithromycin
n=218 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=203 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Change in Weight Over Time
|
12.5 kg
Standard Deviation 3.0
|
12.6 kg
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 180 days post-treatmentHeight or length will be measured at all follow-ups and height-for-age z-scores will be calculated.
Outcome measures
| Measure |
Azithromycin
n=200 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=189 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Change in Height Over Time
|
91.6 cm
Standard Deviation 11.5
|
91.3 cm
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Azithromycin
n=185 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=177 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Number of Participants With Infantile Hypertrophic Pyloric Stenosis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 days post-treatmentVital status will be assessed at all follow-up time points. Mortality will be defined as death within the study period. Date of death will be collected.
Outcome measures
| Measure |
Azithromycin
n=185 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=177 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 180 days post-treatmentNumber of Participants Positive for Malaria. Blood smears (thin and thick) for malaria will be collected at all follow-ups to determine malaria infection status.
Outcome measures
| Measure |
Azithromycin
n=185 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=177 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Malaria Status
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 14 days post-treatmentCaregivers will be asked if the child has been taken to the health post since the last visit and why
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=209 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Adverse Events
|
44 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: We were able to follow up with 200 children in the azithromycin group and 191 children in the placebo group.
Total resistance read numbers in 12 classes: Aminoglycosides, Cationic antimicrobial peptides, Elfamycins, MLS, Metronidazole, Multi-drug resistance, Phenicol, Rifampin, Sulfonamides, Tetracyclines, Trimethoprim, and Beta-lactams. We compare the read numbers of macrolide resistance in each treatment group. A higher read number indicates more resistance.
Outcome measures
| Measure |
Azithromycin
n=200 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=191 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Genotypic Resistance
|
7547 number of reads
|
13077 number of reads
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The Inflammatory marker changes data is not collected in this study
Measured by C-reactive protein
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 days post-treatmentPopulation: Data is not collected
Measured using BugFACS from whole blood and stool
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 days post-treatmentTo be measured using mid-upper arm circumference
Outcome measures
| Measure |
Azithromycin
n=200 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=189 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Nutritional Status
|
14.3 cm
Standard Deviation 1.2
|
14.5 cm
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentPopulation: No data was collected/analyzed.
Next generation sequencing
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeks post-treatmentL-1 norm distance on bacterial reads (intestinal) from rectal swabs of 50 children. L1-norm distance on bacterial reads (intestinal) - L1 norm is equivalent to Shannon's diversity. Shannon's Alpha Diversity combines richness and diversity. Shannon's index of diversity (alpha diversity) measures both the number of species and the inequality between species abundances. A large value is given by the presence of many species with well balanced abundances.
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=208 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
L-1 Norm Distance on Bacterial Reads (Intestinal)
|
32.98 Index score
Standard Deviation 9.37
|
43.15 Index score
Standard Deviation 12.82
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentL-2 norm distance on bacterial reads (intestinal) from rectal swabs of 450 children. L2-norm distance on bacterial reads (intestinal) - L2 norm is equivalent to Simpson's diversity. Simpson's Alpha Diversity were obtained at Baseline and Post-treatment in this study. The minimum of Simpson's index of diversity is 0, there is no maximum. Higher Simpson's index of diversity means more diverse. There are no subscales.
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=208 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
L-2 Norm Distance on Bacterial Reads (Intestinal)
|
14.81 Index score
Standard Deviation 5.72
|
20.46 Index score
Standard Deviation 7.83
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentReduce in normalized reads for Campylobacter species using DNA-seq from rectal swabs of 450 children. We compare the read numbers of Campylobacter species in each treatment group. Campylobacter is associated with disease. Reduction in Campylobacter species burden may reduce diarrhea-related mortality.
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=208 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Changes in Normalized Reads for Campylobacter Species
|
1886.12 number of reads
|
549.48 number of reads
|
SECONDARY outcome
Timeframe: 2 weeks post-treatmentChao1 total resistance gene determinant richness using DNA-seq from rectal swabs of 450 children. We calculated Chao1 total resistance gene determinant richness across arms. Species richness is the simplest measure of biodiversity and is just a count of the number of different species in a given area.
Outcome measures
| Measure |
Azithromycin
n=221 Participants
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=208 Participants
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
Resistome
|
3.98 number of species
Standard Deviation 3.5
|
2.23 number of species
Standard Deviation 2.02
|
Adverse Events
Azithromycin
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Azithromycin
n=221 participants at risk
A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.
Azithromycin: Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
|
Placebo
n=209 participants at risk
A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.
Placebo: Oral suspension of placebo for azithromycin
|
|---|---|---|
|
General disorders
Fever (self-report)
|
16.7%
37/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
20.1%
42/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
|
General disorders
Abdominal pain
|
0.00%
0/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
0.96%
2/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
|
Gastrointestinal disorders
Vomiting
|
7.2%
16/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
1.9%
4/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
|
Gastrointestinal disorders
Diarrhea
|
8.1%
18/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
6.2%
13/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
|
Gastrointestinal disorders
Constipation
|
0.45%
1/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
0.48%
1/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/221 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
0.48%
1/209 • 14 days following azithromycin or placebo treatment. Deaths were assessed up to 180 days post-treatment. Adverse Events were assessed 14 days following azithromycin or placebo treatment
We report adverse events and clinic visits during the 2-week period immediately after treatment to better understand the safety and short-term impact of azithromycin compared with placebo in young children.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place