OBJECTIVES: To determine the efficacy and safety of adjunctive corticosteroid therapy in clinical Pneumocystis jiroveci pneumonia (PCP) in infants exposed to HIV infection.
DESIGN: Double-blind randomised placebo-controlled trial. METHODS: Infants with a clinical diagnosis of PCP, based on an 'atypical' pneumonia with : (i) hypoxia out of proportion to the clinical findings on auscultation; (ii) C-reactive protein count less than 10 mg/l; (iii) lactate dehydrogenase level above 500 IU/l; (iv) compatible chest radiograph findings; and (v) positive HIV enzyme-linked immunosorbert assay (ELISA) were included in the study.
Patients were randomised to receive either prednisone or placebo. The protocol provided for the addition of prednisone to the treatment at 48 hours if there was clinical deterioration or an independent indication for steroid therapy. Other treatment was carried out in accordance with established guidelines. The primary study endpoint was in-hospital survival. Secondary outcome was time from admission to the first day of mean oxygen saturation above 90% in room air.
RESULTS: One hundred patients were included, 47 in the prednisone and 53 in the placebo group. Patients in the prednisone group had a 43% better chance of survival than the placebo group (hazard ratio (HR) 0.57, 95% confidence interval (CI) 0.30 - 1.07, p =0.08). No significant differences could be demonstrated between groups with regard to other parameters of recovery. CONCLUSIONS: in HIV-exposed infants with clinical PCP, adjunctive corticosteroid treatment does not appear to add benefit regarding time to recovery or oxygen independency, but early administration may improve survival. A large multicentred trial is needed to confirm these findings.