A single dose of the broad-spectrum antibiotic azithromycin did not change the percentage of US COVID-19 patients who reported symptoms for 14 days, according to a randomized controlled trial published late last week. GLASS.
The study, led by researchers at the University of California, San Francisco (UCSF), involved 263 non-hospital adult COVID-19 patients receiving a 1.2-gram dose of oral azithromycin (171) or placebo (92) 2020 to March 2021.
Participants who had tested positive for COVID-19 in the past 7 days were monitored for up to 21 days to assess whether the antibiotic would prevent the disease from progressing for 14 days. Most patients had symptoms at onset.
There was no significant difference in the proportion of participants who did not report symptoms for up to 14 days (50% each), regardless of age. The differences between the two groups, however, were significant in terms of many outcomes.
Five participants in the azithromycin group were hospitalized on the 21st day, compared to zero among the placebo recipients (prevalence difference, 4%), a significant difference that requires further investigation, the researchers noted. Reasons for admission to the hospital were difficulty breathing (2 patients), pneumonia (1), low oxygen level (1) and severe abdominal pain (1).
Similarly, 14% of azithromycin recipients reported visiting an emergency department or emergency unit by day 21, compared with 3% of those receiving placebo.
More participants in the azithromycin group reported gastrointestinal discomfort on day 3 than in the placebo group, such as diarrhea (41% vs. 17%), abdominal pain (17% vs. 1%), and nausea (22% vs. 10%). . No serious adverse reactions or deaths were reported in either group.
The mean age of the participants was 43 years, 66% were women, 57% were White, 29% were Latino or Hispanic and 76% completed the test. The study’s data monitoring and security board completed the study earlier, on March 16, after an interim analysis showed futility.
Threat of antibiotic resistance
Previous randomized clinical trials involving inpatients and outpatients with mumps have not identified a benefit from azithromycin in the treatment of COVID-19, whether administered with or without the antihypertensive drug hydroxychloroquine, the researchers noted.
In a UCSF news release, study lead author Catherine Oldenburg, ScD, MPH, said the findings did not support the routine treatment of outpatients COVID-19 with azithromycin, a low-cost antibiotic widely used in patients in the United States. and abroad. “The hypothesis is that it has anti-inflammatory properties that can help prevent progression if treated early in the disease,” he said. “We did not find it that way.”
Oldenburg noted that most previous trials of azithromycin as a treatment for COVID-19 involved serious hospitalized patients. “Our journal is one of the first placebo-controlled studies to show no role for azithromycin in outpatients,” he said.
Indeed, the researchers said that excessive use of antimicrobial drugs such as azithromycin in the treatment of COVID-19 could lead to antibiotic resistance. “Extensive use of azithromycin for COVID-19 in the absence of clear bacterial indication may contribute to the selection of resistance,” they wrote.