Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition: the amour trial
Ended Project Grant Awarded Last action
- Award ID
- R01HD111532
- Recipient
-
The Regents Of The University Of California. San Francisco UEI KMH5K9V7S518
- Awarding agency
-
National Institute of Child Health and Human Development
National Institutes of Health, Department of Health and Human Services
- Obligated
- $6,440,229
Award facts
- Assistance listing
- 93.865 Child Health and Human Development Extramural Research
- Completion date
- Place of performance
- San Francisco, CA 94143, USA
Award details come from USAspending.gov.
Description
- Abstract
- Amoxicillin is recommended by the world health organization (who) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes. Two randomized placebo- controlled randomized trials have evaluated amoxicillin for uncomplicated SAM and have found conflicting results. These results may indicate either that antibiotics are not helpful for the management of uncomplicated SAM, or that a better antibiotic is needed. Recently, we demonstrated that biannual mass azithromycin distribution as a single oral dose reduces all-cause child mortality in sub-saharan africa. Children with uncomplicated SAM, who have an elevated risk of mortality relative to their well-nourished peers, may particularly benefit from presumptive azithromycin treatment. Our pilot data demonstrated feasibility in rapid enrollment of children with uncomplicated SAM in our study area, and showed no significant difference between azithromycin and amoxicillin, demonstrating equipoise for a full-scale trial. Here, we propose an individually randomized trial in which children will be randomized to a) azithromycin, b) amoxicillin, or c) placebo, and evaluated for differences in weight gain, nutritional recovery, and the GUT microbiome. The results of this study will strengthen the evidence base for policy related to the use of antibiotics as part of the management of uncomplicated SAM, including additional evidence of amoxicillin versus placebo as well as evaluation of an antibiotic class that has not been considered for uncomplicated SAM, which may lead to changes in guidelines for treatment.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | -$123,413 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $14,651 | |
| Amendment | $14,651 | |
| Amendment | -$146,513 | |
| Amendment | -$146,513 | |
| Amendment | $193,446 | |
| Amendment | $193,446 | |
| Amendment | $131,862 | |
| Amendment | $131,862 | |
| Amendment | $131,862 | |
| Amendment | $422,410 | |
| Amendment | $422,410 | |
| Amendment | $422,410 | |
| Amendment | $61,941 | |
| Amendment | $61,941 | |
| Amendment | $557,470 | |
| Amendment | $557,470 | |
| Amendment | $557,470 | |
| Amendment | $557,470 | |
| Amendment | $557,470 | |
| Amendment | $622,142 | |
| Amendment | $622,142 | |
| Original award | $622,142 |
Show all 25
Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Centre De Recherche En Sante De Nouna | $411,187 |
Quick answers
Who received award R01HD111532?
R01HD111532 was awarded to The Regents Of The University Of California. San Francisco by National Institute of Child Health and Human Development (National Institutes of Health) on December 8, 2023.
How much is award R01HD111532 worth?
$6,440,229 has been obligated on R01HD111532.
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