A Phase 3 interventional study of Azithromycin and Amoxicillin in Uncomplicated Severe Acute Malnutrition, sponsored by University of California, San Francisco. Completed at 1 site in Burkina Faso. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by University of California, San Francisco · Phase 3, Interventional, and Treatment
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.
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Exclusion Criteria:
children in this arm will receive one dose of azithromycin
Drug: Azithromycin
Children in this arm will receive a 7 day course of amoxicillin (standard of care)
Drug: Amoxicillin
Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
Also known as: Zithromax
Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Weight Gain
Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks
Time frame: 8 weeks
Nutritional Recovery - Primary Definition
Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length is equal to or more than -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is equal to or more than 125 mm and the child have had no oedema for at least 2 weeks. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
Time frame: 8 weeks
Nutritional Recovery - Secondary Definition
Summarize the cumulative proportion recovered by arm. Children are considered recovered if they had mean upper arm circumference \> 12.5 or weight-for-height/length \> -2 for 2 consecutive measurements. Additionally, it includes children who had had mean upper arm circumference \>12.5 or weight-for-height/length \> -2 on their final measurement, regardless of whether they met these criteria on the previous visit.
Time frame: 8 weeks
Malaria
Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.
Time frame: 8 weeks
Mortality
Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.
Time frame: 8 weeks
Length/Height-for-age Z-score (LAZ/HAZ)
Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
Time frame: 8 weeks
Mid-Upper Arm Circumference (MUAC)
Mid-upper arm circumference will be measured at all follow-up time points
Time frame: 8 weeks
Weight-for-Age Z-scores (WAZ)
Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Underweight is weight-for-age below the -2 z-score line. Severely underweight is below the -3 z-score line.
Time frame: 8 weeks
Weight-for-Height Z-score (WHZ)
Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Overweight is weight-for-length/height above the 2 z-score line. Severely overweight; weight-for-length/height above the 3 z-score line
Time frame: 8 weeks
Intestinal Microbiome
baseline and 8 week intestinal microbiome will be compared between the 2 arms alpha diversity using inverse Simpson's index and Shannon's index, expressed in effective number. The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. An index of 0 indicates a community that only has one species. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. The Simpson's Diversity Index is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases. The value ranges between 0 and 1, where 1 represents infinite diversity and 0, no diversity.
Time frame: Baseline, 8 weeks
| Milestone | Azithromycin | Amoxicillin |
|---|---|---|
| Started | 161 | 140 |
| Completed | 161 | 140 |
| Not completed | 0 | 0 |
Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks
| g/kg/day | Azithromycin | Amoxicillin |
|---|---|---|
| Weight Gain | 1.8 ± 2.1 | 2.0 ± 2.2 |
Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length is equal to or more than -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is equal to or more than 125 mm and the child have had no oedema for at least 2 weeks. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
| Participants | Azithromycin | Amoxicillin |
|---|---|---|
| Nutritional Recovery - Primary Definition | 56 | 48 |
Summarize the cumulative proportion recovered by arm. Children are considered recovered if they had mean upper arm circumference \> 12.5 or weight-for-height/length \> -2 for 2 consecutive measurements. Additionally, it includes children who had had mean upper arm circumference \>12.5 or weight-for-height/length \> -2 on their final measurement, regardless of whether they met these criteria on the previous visit.
| Participants | Azithromycin | Amoxicillin |
|---|---|---|
| Nutritional Recovery - Secondary Definition | 98 | 87 |
Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.
| Participants | Azithromycin | Amoxicillin |
|---|---|---|
| Malaria | 13 | 15 |
Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.
| Participants | Azithromycin | Amoxicillin |
|---|---|---|
| Mortality | 2 | 1 |
Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
| Z-score | Azithromycin | Amoxicillin |
|---|---|---|
| Length/Height-for-age Z-score (LAZ/HAZ) | -2.3 ± 1.5 | -2.37 ± 1.5 |
Mid-upper arm circumference will be measured at all follow-up time points
| cm | Azithromycin | Amoxicillin |
|---|---|---|
| Mid-Upper Arm Circumference (MUAC) | 12.4 ± 0.8 | 12.3 ± 0.8 |
Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Underweight is weight-for-age below the -2 z-score line. Severely underweight is below the -3 z-score line.
| Z-score | Azithromycin | Amoxicillin |
|---|---|---|
| Weight-for-Age Z-scores (WAZ) | -2.58 ± 1.1 | -2.65 ± 1.1 |
Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores. A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean. Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards: Overweight is weight-for-length/height above the 2 z-score line. Severely overweight; weight-for-length/height above the 3 z-score line
| Z-score | Azithromycin | Amoxicillin |
|---|---|---|
| Weight-for-Height Z-score (WHZ) | -1.89 ± 1.2 | -1.95 ± 1.0 |
baseline and 8 week intestinal microbiome will be compared between the 2 arms alpha diversity using inverse Simpson's index and Shannon's index, expressed in effective number. The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. An index of 0 indicates a community that only has one species. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity. The Simpson's Diversity Index is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases. The value ranges between 0 and 1, where 1 represents infinite diversity and 0, no diversity.
| Index | Azithromycin | Amoxicillin |
|---|---|---|
| Baseline Simpson's Index | 4.0 ± 2.6 | 5.1 ± 3.5 |
| Baseline Shannon's Index | 6.6 ± 4.4 | 8.3 ± 5.6 |
| Week 8 Simpson's Index | 4.5 ± 2.8 | 5.3 ± 2.9 |
| Week 8 Shannon's Index | 7.5 ± 4.6 | 9.1 ± 5.8 |
Collected over 8 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Azithromycin | 2/161 (1.2%) | 41/161 (25.5%) | 106/161 (65.8%) |
| Amoxicillin | 1/140 (0.7%) | 43/140 (30.7%) | 100/140 (71.4%) |
| Event | Azithromycin | Amoxicillin |
|---|---|---|
| Clinic visitSurgical and medical procedures | 41/161 | 42/140 |
| HospitalizationSurgical and medical procedures | 2/161 | 3/140 |
| DeathCardiac disorders | 2/161 | 1/140 |
| Event | Azithromycin | Amoxicillin |
|---|---|---|
| feverInfections and infestations | 82/161 | 80/140 |
| DiarrheaGastrointestinal disorders | 46/161 | 44/140 |
| VomitingGastrointestinal disorders | 33/161 | 23/140 |
| skin rashSkin and subcutaneous tissue disorders | 7/161 | 16/140 |
| constipationGastrointestinal disorders | 7/161 | 7/140 |
| Abdominal painGastrointestinal disorders | 7/161 | 6/140 |
| Age, Categorical(Participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| <=18 years | 161 | 140 | 301 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(months) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Mean | 16.9 ± 8.4 | 16.5 ± 8.2 | 16.7 ± 8.4 |
| Sex: Female, Male(Participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Female | 92 | 77 | 169 |
| Male | 69 | 63 | 132 |
| Race (NIH/OMB)(Participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 161 | 140 | 301 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Burkina Faso | 161 | 140 | 301 |
| Curently breastfeeding(Participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Number | 108 | 104 | 212 |
| Exclusively breastfeeding(Participants) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Number | 10 | 11 | 21 |
| Number of children under 5 in the household(Children) | Azithromycin | Amoxicillin | Total |
|---|---|---|---|
| Mean | 2 ± 1.7 | 1.9 ± 1.5 | 1.9 ± 1.6 |
5 further baseline measures are reported on the registry.
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Studies of the drug tested here: Azithromycin
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