Discontinuing β-lactam treatment after 3 days for patients with community-acquired pneumonia in non-critical care wards (PTC): a double-blind, randomised, placebo-controlled, non-inferiority trial
The Lancet Published online 27 March, 2021 |
Digest author(s): Shaikha Aleissaee, Emer Kelly (e-Learning Director), 20 October, 2021
Pneumonia is one of the most common reasons for hospital admission. Shortening antibiotic courses may result in reduced antibiotic resistance, improved patient adherence and decreased cost and side effects. The recommended treatment durations vary between guidelines and range from 5 to 8 days. This study was a non-inferiority trial to compare a 3 day versus 8 day course of antibiotics in patient who were clinically stable after 3 days of β-lactam treatment.
This a double-blinded, randomised, placebo-controlled study that took place in 16 French hospitals. Adult patients, who were admitted to non-critical wards with a diagnosis of community acquired pneumonia, were assessed to be enrolled to the study after 3 days of β-lactam treatment (mostly amoxicillin plus clavulanate) and had achieved clinical stability by day 3 of treatment. Around 310 patients were randomly assigned to either additional 5 days treatment of B-lactam or placebo in (1:1) distribution. Median age of the patients was 73 and average pneumonia severity index was 82.
The primary outcome was cure at day 15 which was defined as resolution of fever, improvement of respiratory symptoms, and no further antibiotics courses required. In intention-to-treat analysis 77% of the placebo group and 68% in the additional treatment group achieved cure at day 15. The difference between the groups was 9.42%, which achieved the non-inferiority margin of 10%. Similar results were obtained in the per-protocol analysis. The study also looked at cure at day 30, mortality at day 30, frequency and severity of side effects, length of hospital stay and patient pneumonia symptoms as secondary outcomes. There was no significant difference between both groups.
This study provides evidence that shorter duration antibiotics (3 days) can be used. However, around 706 patients were screened to be included in the study and only 310 met the criteria. Exclusion was due to severity of pneumonia, presence of other comorbidities, immunosuppression, aspiration pneumonia and hospital acquired pneumonia. This implies that shorter duration can be used only in selected patients. In addition, the study did not provide data about the cause of community acquire pneumonia. It is common that viral causes may result in milder disease, which will not benefit from antibiotic therapy.