Adjunctive Corticosteroid Treatment of Clinical PCP Pneumonia in Infants Less than 18 Months of Age : a Randomized Controlled Trial

ABSTRACT

"Objectives. To determine the efficacy and safety of adjunctive corticosteroid therapy in clinical PCP pneumonia (Pneumocystis jiroveci pneumonia) 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 1) hypoxia out of proportion to the clinical findings on auscultation; 2) CRP less than 10 IU; 3) LDH above 500 IU; 4) compatible CXR findings and 5) positive HIV ELISA test 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. 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 (HR 0.57; 95CI 0.30-1.07; p=0.08). No significant differences could be demonstrated between groups in respect of other parameters of recovery. Conclusions. In HIV exposed infants with clinical PCP pneumonia; adjunctive corticosteroid treatment does not appear to add benefit regarding time to recovery or oxygen independency; but early administration may improve survival. A large multi-centred trial is needed to confirm these findings.The primary study endpoint was in hospital survival. Secondary outcome was time from admission to the first day of mean oxygen saturation above 90"