Immunology, Medical News, Pediatrics, Pharmaceuticals

Largest randomized-controlled trial of amoxicillin for treating chest infections in children finds no significant improvement

The study found that there was only a small, non-significant difference between the two groups, with a reduction in the duration of symptoms in the antibiotic group of 13%.

According to a recently published study which conducted the largest randomized-controlled trial for the antibiotic, amoxicillin, to date, has been found to be no more successful at treating chest infections than using a placebo. Amoxicillin is commonly used to treat chest infections in children such as bronchitis and pneumonia.

While research has demonstrated that antibiotics are ineffective for uncomplicated chest infections in adults, the same amount of research has not been done in children.

The research enlisted 432 children aged six months to twelve years old with acute uncomplicated chest infections from primary care practices across England and Wales, who were then randomly selected to receive amoxicillin or a placebo three times a day for seven days.

Amoxicillin is available as a liquid for children and those who find it difficult to swallow tablets.

The authors report that ARTIC PC, the double-blind, randomized, placebo-controlled trial, which was conducted at 56 general practices in England, is one of very few studies that focus on antibiotic efficacy in children presenting chest infections.

The study states, “[ARTIC PC] was designed to be able to detect a clinically important 3-day improvement in symptom duration (an HR of 1·7)—about a 15% difference considering a total illness duration of 20–25 days documented by a systematic review,41 or roughly a 20% improvement for an illness lasting 14 days based on the placebo group of our trial. A 3-day improvement in a subgroup was judged to be important enough to be worth prescribing an antibiotic, given the public health danger from antibiotic resistance.”

The study found that there was only a small, non-significant difference in the duration of symptoms between the two groups— children who received the placebo had symptoms that were rated moderately bad or worse for around 6 days on average after seeing the doctor, while those who received antibiotics improved only 13% faster.

This was even true for groups of children in which the doctor heard noises in the chest, the child had a fever, the child was assessed as more ill, the child coughed up phlegm or had a rattly chest, or the child was short of breath.

“Children given amoxicillin for chest infections where the doctor does not think the child has pneumonia do not recover much [quicker],” said Paul Little, Professor of Primary Care Research at the University of Southampton.

“Indeed, using amoxicillin to treat chest infections in children not suspected of having pneumonia is not likely to help and could be harmful,” Dr. Little added. “Overuse of antibiotics, which is dominated by prescribing of antibiotics in primary care, particularly when they are ineffective, can lead to side effects and the development of antibiotic resistance. Antibiotic resistance is one of the biggest threats to the health of the public, and in future could make much of what is currently routine medical practice very difficult or impossible – such having surgical operations or supporting people who are being treated for cancer.”


The study was published in The Lancet, on September 22nd, 2021.

Abstract. Antibiotic resistance is a global public health threat. Antibiotics are very commonly prescribed for children presenting with uncomplicated lower respiratory tract infections (LRTIs), but there is little evidence from randomised controlled trials of the effectiveness of antibiotics, both overall or among key clinical subgroups. In ARTIC PC, we assessed whether amoxicillin reduces the duration of moderately bad symptoms in children presenting with uncomplicated (non-pneumonic) LRTI in primary care, overall and in key clinical subgroups.

Little P, Francis NA, et al. Antibiotics for lower respiratory tract infection in children presenting in primary care in England (ARTIC PC): a double-blind, randomised, placebo-controlled trial. Lancet. 2021 Sep 22:S0140-6736(21)01431-8. doi: 10.1016/S0140-6736(21)01431-8. Epub ahead of print. PMID: 34562391.

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