Adjunctive corticosteroids in non-AIDS patients with severe Pneumocystis jirovecii pneumonia (PIC): a multicentre, double-blind, randomised controlled trial
Abstract
BACKGROUND
Pneumocystis jirovecii pneumonia in HIV-negative immunocompromised patients has a hospital mortality rate of 30-50%. Adjunctive corticosteroids improve outcomes of P jirovecii pneumonia in HIV-positive patients. The aim of this trial was to assess the effects of early adjunctive corticosteroid therapy for 21 days in HIV-negative patients with P jirovecii pneumonia responsible for acute hypoxaemia respiratory failure.
METHODS
This multicentre, double-blind, randomised controlled trial was conducted at 27 hospitals in France. We included patients with acute respiratory failure, aged 18 years or older with mild-to-severe hypoxaemia, microbiological documentation of P jirovecii pneumonia, and anti-Pneumocystis treatment duration of less than 7 days. Patients were randomly assigned (1:1) to the corticosteroid group (adjunctive corticosteroid therapy of methylprednisolone intravenously, 30 mg twice per day from days 1 to 5, 30 mg once per day from days 6 to 10, and 20 mg once per day until day 21) or placebo group (2 mL or 3 mL syringes of isotonic saline intravenously) using a web-based system. Permutation blocks of fixed size unknown to the local investigators were used. Stratification factors were centre, long-term corticosteroid treatment started more than 1 month before enrolling in the trial, underlying disease (malignancy vs other), and oxygen needs at randomisation (<6 vs ≥6 L per min). The primary outcome was all-cause 28-day mortality defined as the proportion…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 226 participants or records.
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