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Study was halted due to low follow-up rates and issues with data collection
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| Name | Class |
|---|---|
| The Taimaka Project | UNKNOWN |
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This randomized controlled trial is designed to determine the effect of administration of azithromycin compared to amoxicillin as part of the treatment of uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months on weight gain and nutritional recovery. The investigators will randomize children presenting to Taimaka-run nutritional programs at health centers in Gombe State, Nigeria to a single dose of oral azithromycin or a short course of oral amoxicillin upon admission into the program. Apart from the administration of antibiotics, all children will receive standard outpatient treatment for uncomplicated SAM as specified in the guidelines of the government of Nigeria, which includes therapeutic feeding with ready-to-use therapeutic food (RUTF). Enrolled children will be followed weekly at each routine clinic follow-up visit up until nutritional recovery. All enrolled children will return for a final study visit at 8 weeks following enrollment. Anthropometric and vital status data will be collected at each follow-up visit. Weight gain and nutritional recovery over the 8-week study period will be compared by arm as a primary outcome and at 12 weeks as a secondary outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Experimental | Children in this arm will receive one dose of amoxicillin. |
|
| Amoxicillin | Active Comparator | Children in this arm will receive a 5-day course of amoxicillin (standard care). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain at 8 Weeks | Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Nutritional Recovery at 8 Weeks | Nutritional recovery will be defined as a child having WHZ ≥ -2 on two consecutive visits and no acute complication or edema for the past 7 days AND / OR MUAC of ≥ 125mm on 2 consecutive visits and no acute complication or edema for the past 7 days. Children will be considered recovered or not recovered using these criteria Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WHZ < -3 standard distributions below the median is defined as severely wasted. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Gain Over 12 Weeks | Weight will be measured at baseline and weekly follow up visits for 8 weeks, and at 12 weeks after admission to the program. Weight gain will be defined as grams per kilogram per day (g/day). | 12 weeks |
| Time to Recovery |
Inclusion criteria (all must be met):
Exclusion criteria (any excludes):
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| Name | Affiliation | Role |
|---|---|---|
| Kieran S O'Brien, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Tamaika Project | Gombe | Gombe State | 760252 | Nigeria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Amoxicillin | Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF. |
| FG001 | Azithromycin | Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Amoxicillin | Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Gain at 8 Weeks | Weight will be measured at baseline and weekly follow ups, and weight gain will be calculated at 8 weeks in g/day | 96 children in Amoxicillin arm and 120 children in Azithromycin arm had anthropometry form collected between the 8 weeks window (42 to 70 days) | Posted | Mean | Standard Deviation | g/day | 8 weeks |
|
Parents or guardians of enrolled children will be instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. All cause-mortality will be monitored until 12 weeks.
Parents or guardians of enrolled children were instructed to report any adverse events experienced within the 7 days following the enrollment visit, by phone or in person. There were 133 participants in Amoxicillin arm and 142 participants in Azithromycin arm had follow-ups at 7 days.
All cause-mortality was monitored until 12 weeks. There were 42 participants in Amoxicillin arm and 58 participants in Azithromycin arm had follow-ups at 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Amoxicillin | Children in this arm will receive a 5-day course of amoxicillin (standard care). Amoxicillin: Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death in 7 days | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| weight loss | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine E. Oldenburg | UCSF FI Proctor | 415-502-8843 | catherine.oldenburg@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2023 | Dec 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D000658 | Amoxicillin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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|
| Amoxicillin | Drug | Children enrolled in the trial and randomized to receive amoxicillin will receive a 5-day course of amoxicillin to be given in twice-daily doses of 15 mg/kg per the Nigeria guidelines for severe acute malnutrition. The first dose will be administered at the time of enrollment, and the remaining doses will be administered by the caregiver at home. Enrolled children will also receive RUTF. |
|
| 8 weeks |
Time from enrollment to nutritional recovery will be calculated in days by subtracting the date of enrollment from the date of nutritional recovery.
| 12 weeks |
| Nonresponse at 8 Weeks | Number of children with nonresponse will be documented if a child does not meet the criteria for nutritional recovery at 8 weeks after enrollment. | 8 weeks |
| Number of Participants Who Transferred to Inpatient Care | The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded. | 12 weeks |
| Mortality by 8 Weeks | Vital status will be assessed at baseline and at weekly follow up visits for 8 weeks, and mortality will be defined as death during the study period. Date of death will be recorded. | 8 weeks |
| Mortality by 12 Weeks | Vital status will be assessed at baseline, weekly follow up visits for 8 weeks, and at 12 weeks, and mortality will be defined as death during the study period. Date of death will be recorded. | 12 weeks |
| Clinical Signs of Infection | Number of participants with clinical sign of infection will be recorded At baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit, including care-giver reported experience of fever, diarrhea, vomiting, and respiratory infection/cough and clinical diagnoses made at by site personnel | 12 weeks |
| Height-for-age Z-score (HAZ) | Height or length will be measured monthly (baseline and the 4-, 8-, and 12-week follow up visits) and height-for-age z-scores will be calculated. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A HAZ < -2 standard distributions below the median is defined as stunted, while a HAZ < -3 standard distributions below the median is defined as severely stunted. | 12 weeks |
| Mid-upper Arm Circumference (MUAC) | Mid-upper arm circumference (centimeters) will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit). | 12 weeks |
| Weight-for-age Z-score (WAZ) | Weight will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit) and weight-for-age z-scores will be calculated. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WAZ < -2 standard distributions below the median is defined as underweight, while a WAZ < -3 standard distributions below the median is defined as severely underweight. | 12 weeks |
| Weight-for-height Z-score (WHZ) | Weight and height, assessed at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit), will be used to calculate weight-for-height z-scores. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WAZ < -3 standard distributions below the median is defined as severely wasted. | 12 weeks |
| Malaria | Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status. Positivity rate will be compared between arms | 8 weeks |
| BG001 | Azithromycin | Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. |
| BG002 | Total | Total of all reporting groups |
| month |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Azithromycin | Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. |
|
|
| Secondary | Number of Participants With Nutritional Recovery at 8 Weeks | Nutritional recovery will be defined as a child having WHZ ≥ -2 on two consecutive visits and no acute complication or edema for the past 7 days AND / OR MUAC of ≥ 125mm on 2 consecutive visits and no acute complication or edema for the past 7 days. Children will be considered recovered or not recovered using these criteria Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WHZ < -3 standard distributions below the median is defined as severely wasted. | 96 children in Amoxicillin arm and 120 children in Azithromycin arm had anthropometry form collected between the 8 weeks window (42 to 70 days) | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | Weight Gain Over 12 Weeks | Weight will be measured at baseline and weekly follow up visits for 8 weeks, and at 12 weeks after admission to the program. Weight gain will be defined as grams per kilogram per day (g/day). | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Mean | Standard Deviation | g/day | 12 weeks |
|
|
|
| Other Pre-specified | Time to Recovery | Time from enrollment to nutritional recovery will be calculated in days by subtracting the date of enrollment from the date of nutritional recovery. | Posted | Mean | Standard Deviation | days | 12 weeks |
|
|
|
| Other Pre-specified | Nonresponse at 8 Weeks | Number of children with nonresponse will be documented if a child does not meet the criteria for nutritional recovery at 8 weeks after enrollment. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | Number of Participants Who Transferred to Inpatient Care | The occurrence, date, and reason for transfer from outpatient to inpatient treatment will be recorded. | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Mortality by 8 Weeks | Vital status will be assessed at baseline and at weekly follow up visits for 8 weeks, and mortality will be defined as death during the study period. Date of death will be recorded. | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| Other Pre-specified | Mortality by 12 Weeks | Vital status will be assessed at baseline, weekly follow up visits for 8 weeks, and at 12 weeks, and mortality will be defined as death during the study period. Date of death will be recorded. | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Clinical Signs of Infection | Number of participants with clinical sign of infection will be recorded At baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit, including care-giver reported experience of fever, diarrhea, vomiting, and respiratory infection/cough and clinical diagnoses made at by site personnel | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Other Pre-specified | Height-for-age Z-score (HAZ) | Height or length will be measured monthly (baseline and the 4-, 8-, and 12-week follow up visits) and height-for-age z-scores will be calculated. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A HAZ < -2 standard distributions below the median is defined as stunted, while a HAZ < -3 standard distributions below the median is defined as severely stunted. | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Mean | Standard Deviation | z score | 12 weeks |
|
|
|
| Other Pre-specified | Mid-upper Arm Circumference (MUAC) | Mid-upper arm circumference (centimeters) will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit). | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Mean | Standard Deviation | centimeters (cm) | 12 weeks |
|
|
|
| Other Pre-specified | Weight-for-age Z-score (WAZ) | Weight will be measured at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit) and weight-for-age z-scores will be calculated. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WAZ < -2 standard distributions below the median is defined as underweight, while a WAZ < -3 standard distributions below the median is defined as severely underweight. | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Mean | Standard Deviation | z score | 12 weeks |
|
|
|
| Other Pre-specified | Weight-for-height Z-score (WHZ) | Weight and height, assessed at all follow-up time points (baseline, weekly follow up visits for 8 weeks, and at the 12-week follow up visit), will be used to calculate weight-for-height z-scores. Anthropomorphic outcomes are defined according to the World Health Organization's 2006 Child Growth Standards A z-score of 0 represents the population median. The z-score will be positive if the data value lies above the mean, and it will be negative if the value lies below the median. A WHZ < -2 standard distributions below the median is defined as moderately wasted, while a WAZ < -3 standard distributions below the median is defined as severely wasted. | 42 children in Amoxicillin arm and 58 children in Azithromycin arm had anthropometry form collected between the 12 weeks window (70 to 98 days) | Posted | Mean | Standard Deviation | z score | 12 weeks |
|
|
|
| Other Pre-specified | Malaria | Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status. Positivity rate will be compared between arms | 55 children in Amoxicillin arm and 66 children in Azithromycin arm had malaria test between the 8 weeks window (42 to 70 days) | Posted | Count of Participants | Participants | 8 weeks |
|
|
|
| 4 |
| 42 |
| 1 |
| 133 |
| 1 |
| 133 |
| EG001 | Azithromycin | Children in this arm will receive one dose of amoxicillin. Azithromycin: Children enrolled in the trial and randomized to receive azithromycin will receive a single dose of azithromycin at 20 mg/kg up to the maximum adult dose of 1g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. | 3 | 58 | 0 | 142 | 3 | 142 |
| severe fever | General disorders | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| Organic Chemicals |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |