C Figueiredo-Mello1, P Naucler2, M D Negra3, A S Levin4. 1. Department of Infectious Diseases, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil; Department of Education and Research, Instituto de Infectologia Emílio Ribas, São Paulo, Brazil. Electronic address: claudiamello@ymail.com. 2. Department of Medicine Solna, Infectious Diseases Unit, Karolinska Institutet, Stockholm, Sweden; Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden. 3. Instituto de Infectologia Emílio Ribas, São Paulo, Brazil. 4. Department of Infectious Diseases, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Abstract
OBJECTIVES: To evaluate if treatment with ceftriaxone and a macrolide, improved patient outcome when compared with monotherapy with ceftriaxone, in hospitalized patients with human immunodeficiency virus/acquired immunodeficient syndrome (HIV/AIDS) with community-acquired pneumonia (CAP). METHODS:Adult patients with HIV hospitalized due to suspected CAP were randomized to receive one of two regimens, ceftriaxone plus macrolide or ceftriaxone plus placebo, at a 1:1 proportion (Brazilian Clinical Trials Registry: RBR-8wtq2b). The primary outcome was in-hospital mortality and the secondary outcomes were mortality within 14 days, need for vasoactive drugs, need for mechanical ventilation, time to clinical stability and length of hospitalization. RESULTS:A total of 227 patients were randomized, two were excluded after randomization; 225 patients were analysed (112 receivingceftriaxone plus placebo and 113 receiving ceftriaxone plus macrolide). The frequency of the primary outcome, in-hospital mortality, was not statistically different between the regimens: 12/112 (11%) patients who received ceftriaxone plus placebo and 17/113 (15%) who received ceftriaxone plus macrolide died during hospitalization (hazard ratio 1.22, 95% CI 0.57-2.59). We did not find differences between the regimens for any of the secondary outcomes, including mortality within 14 days, which occurred in 5/112 (4%) patients with ceftriaxone plus placebo and in 12/113 (11%) patients with ceftriaxone plus macrolide (relative risk 2.38, 95% CI 0.87-6.53). CONCLUSIONS: Among hospitalized patients with HIV/AIDS with CAP, treatment withceftriaxone and a macrolide did not improve patient outcomes, when compared with ceftriaxone monotherapy.
RCT Entities:
OBJECTIVES: To evaluate if treatment with ceftriaxone and a macrolide, improved patient outcome when compared with monotherapy with ceftriaxone, in hospitalized patients with human immunodeficiency virus/acquired immunodeficient syndrome (HIV/AIDS) with community-acquired pneumonia (CAP). METHODS: Adult patients with HIV hospitalized due to suspected CAP were randomized to receive one of two regimens, ceftriaxone plus macrolide or ceftriaxone plus placebo, at a 1:1 proportion (Brazilian Clinical Trials Registry: RBR-8wtq2b). The primary outcome was in-hospital mortality and the secondary outcomes were mortality within 14 days, need for vasoactive drugs, need for mechanical ventilation, time to clinical stability and length of hospitalization. RESULTS: A total of 227 patients were randomized, two were excluded after randomization; 225 patients were analysed (112 receiving ceftriaxone plus placebo and 113 receiving ceftriaxone plus macrolide). The frequency of the primary outcome, in-hospital mortality, was not statistically different between the regimens: 12/112 (11%) patients who received ceftriaxone plus placebo and 17/113 (15%) who received ceftriaxone plus macrolide died during hospitalization (hazard ratio 1.22, 95% CI 0.57-2.59). We did not find differences between the regimens for any of the secondary outcomes, including mortality within 14 days, which occurred in 5/112 (4%) patients with ceftriaxone plus placebo and in 12/113 (11%) patients with ceftriaxone plus macrolide (relative risk 2.38, 95% CI 0.87-6.53). CONCLUSIONS: Among hospitalized patients with HIV/AIDS with CAP, treatment with ceftriaxone and a macrolide did not improve patient outcomes, when compared with ceftriaxone monotherapy.
Authors: Adriana Paulino Silva; Carolina Toniolo Zenatti; Claudia Figueiredo-Mello; Marinella Della Negra; Anna S Levin; David R Boulware; José Ernesto Vidal Journal: Int J STD AIDS Date: 2020-02-23 Impact factor: 1.359
Authors: Malene Plejdrup Hansen; Anna M Scott; Amanda McCullough; Sarah Thorning; Jeffrey K Aronson; Elaine M Beller; Paul P Glasziou; Tammy C Hoffmann; Justin Clark; Chris B Del Mar Journal: Cochrane Database Syst Rev Date: 2019-01-18