Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children

Chisom Anosike, LECOM School of Pharmacy

It has been stated that the possible causes of maternal and child malnutrition in low-income and middle-income countries are under-nutrition, being overweight and obesity. [1] Malnutrition is considered to be an underlying contributing factor in about 45% of all child deaths, and has been stated to be an underlying factor of acute illnesses including pneumonia or tuberculosis. [2,3] According to the World Health Organization (WHO), amoxicillin is the recommended treatment for uncomplicated severe acute malnutrition. [4]

Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children
Design Randomized, double-blind, placebo-controlled trial; N = 2,412
Objective To examine the effect of routine antibiotic use, as compared with placebo, on nutritional recovery from uncomplicated severe acute malnutrition
Study Groups Amoxicillin group (n = 1,210); placebo group (n = 1,202)
Methods Children six to fifty-nine months of age who had uncomplicated severe acute malnutrition were randomly assigned to receive amoxicillin (80 mg per kg of body weight per day, divided into two daily doses) or placebo for seven days.
Duration October 2012 through November 2013
Primary Outcome Measure To measure nutritional recovery by eight weeks
Baseline Characteristics Characteristics Amoxicillin (n = 1,199) Placebo (n = 1,200)
Child – months 16.8 ± 8.4 16.6 ± 8.7
Mother – years 26.6 ± 6.6 27.1 ± 6.9
Female sex — no. (%) 600 (50.0) 596 (49.7)
Clinical characteristics and medical history
Hemoglobin <11.0 g/dl — no. (%) 869 (72.5) 878 (73.2)
Rapid diagnostic test positive for malaria — no. (%) 652 (54.4) 675 (56.2)
Axillary temperature >38.5°C — no. (%) 63 (5.3) 49 (4.1)
Signs of infection in previous 24 hr — no. (%)
Diarrhea 385 (32.1) 374 (31.2)
Vomiting 71 (5.9) 67 (5.6)
Cough 208 (17.4) 179 (14.9)
Results Overall, 64% of the children enrolled in the study recovered from severe acute malnutrition. In the likelihood of nutritional recovery, risk ratio with amoxicillin versus placebo was 1.05 (95% confidence interval [CI], 0.99 to 1.12). Among children who recovered, the time to recovery was 28 days versus 30 days (p < 0.001).
Adverse Events Common Adverse Events: N/A
Serious Adverse Events: N/A
Percentage that Discontinued due to Adverse Events: N/A
Study Author Conclusions There was no significant benefit of routine amoxicillin use with respect to nutritional recovery among children with uncomplicated severe acute malnutrition in Niger. Findings provide useful information for public health authorities and their implementing partners regarding the routine use of antibiotics in the treatment of uncomplicated severe acute malnutrition.

One key limitation to this study is that there was no separation between malnourished children and children who were malnourished due to human immunodeficiency virus (HIV). An advantage to this study was the use of one regimen, amoxicillin, which is consistent with the WHO guideline. However, one unanswered question is whether another antibiotic regimen would be a better alternative for treating this disorder.


  1. Black RE, Victora CG, Walker SP, et al. Maternal and child undernutrition and overweight in low-income and middle-in- come countries. Lancet 2013;382:427-51.
  2. Naunheim M, Yung KC, Courey M. Timing of hemodynamic changes during transnasal endoscopic surgery. Laryngoscope. 2015;
  3. Hossain MI, Dodd NS, Ahmed T, et al. Experience in managing severe malnutri- tion in a government tertiary treatment fa- cility in Bangladesh. J Health Popul Nutr 2009;27:72-9.
  4. Available at: Accessed October 21, 2015.
  5. Isanaka S, Langendorf C, Berthé F, et al. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016;374(5):444-53.

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