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Comparison of amoxicillin with placebo in the treatment of mild pneumonia (according to WHO criteria) in children aged 2 to 59 months: results of a multicenter double-blind, randomized, placebo-controlled study

In accordance with the recommendations of the World Health Organization for the management of children with acute respiratory disease, if a child suffers from tachypnea, this is considered to be pneumonia and antibiotic therapy is recommended. This approach requires caution, as many children may not have pneumonia and they are given antibiotics unreasonably, which can lead to increased antibiotic resistance of respiratory pathogens.

The aim of a multicentre, double-blind, randomized, placebo-controlled study in Pakistan on the basis of 4 hospitals was to compare the clinical results after 72 hours in children with mild pneumonia determined in accordance with WHO recommendations. with amoxicillin compared to placebo.

Nine hundred children aged 2 to 59 months were randomized to receive oral amoxicillin 45 mg / kg / day for 3 days or a placebo; 873 children completed the study. All children were observed on the 3rd, 5th and 14th days after the end of treatment.

When analyzed in accordance with the protocol, treatment failure on the 3rd day after the end of treatment was observed in 31 of 431 children (7.2%) in the amoxicillin group and 37 people in 442 children (8.3%) of the placebo group. This difference was not statistically significant (odds ratio 0.85, 95% CI 0.5-1.43, p = 0.6). This difference was not statistically significant (odds ratio 0.85, 95% CI 0.5-1.43, p = 0.6). During a multiple analysis, it was found that the anamnestic data on breathing difficulties (odds ratio 2.89, 95% CI 1.29-7.23, p = 0.027) and body temperature above 37, 5 ° C at the time of the onset of the disease (odds ratio of 1.99, 95% CI 1.37-2.9, p = 0.0001) are considered to be risk factors for failure of the treatment on day 5.

Thus, the clinical results in children aged 2 to 59 months with mild pneumonia defined in accordance with WHO recommendations do not differ in patients receiving amoxicillin or placebo. It is necessary to conduct such studies in countries with a high prevalence of pneumonia in children in order to optimize the use of antibiotics in this group of patients.

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