Pneumonia, HIV.
Conditions
Interventions
228 patients were assigned to receive one of two schemes, in 1:1 proportion:
Scheme 1 (114 patients): monotherapy with ceftriaxone plus placebo for at least 7 days,
ceftriaxone 1g IV 12/12h + SF0,9%
Drug
HP3.073.433.101
D002443
Sponsors
Instituto de Infectologia Emílio Ribas
Fundação de Amparo à Pesquisa do Estado de São Paulo
Faculdade de Medicina da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years; HIV infection and community acquired pneumonia. Calculated sample: 228.
Exclusion criteria
Exclusion criteria: Patients with hospitalization for two or more days in the 90 days prior to admission; coming from nursing homes or shelters; if they had health care in those sites; patients that had received intravenous antibiotics; chemotherapy or treatment of bedsores in the last 30 days; in dialysis; with another cause that justifies the lung symptoms on admission; such as pulmonary fibrosis; pneumocystosis; tuberculosis or other non-bacterial disease; pregnant or nursing women; patients allergic to the study medications (ceftriaxone and azithromycin) or patients that had already been randomized in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lethality is the primary outcome of this study. Is expected that we will find a smaller lethality rate in group 2, when compared with group 1, evaluated by comparing the inhospital lethality rate between the two groups with Chi-square test, considering statistically significant at p <0.05. For our sample calculation, was estimated a lethality rate of 29% in group 1 and 11% in group 2. | — |
Secondary
| Measure | Time frame |
|---|---|
| One of the secondary outcomes expected in this study is a smaller lethality in the first 14 days in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a greater frequency of discharged patients in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller need of intensive care admission in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller use of supplemental oxygen in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller use of non-invasive ventilation in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller use of mechanical ventilation in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller rate of hemodynamic instability, defined as use of vasoactive drugs, in group 2 when compared with group 1, by Chi-square test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller length of hospitalization in group 2 when compared with group 1, by MannWhitney or t test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller length of stay in intensive care unit in group 2 when compared with group 1, by MannWhitney or t test, considering statistically significant at p <0.05. One of the secondary outcomes expected in this study is a smaller length of su | — |
Countries
Brazil
Contacts
Public ContactClaudia Figueiredo-Mello
Instituto de Infectologia Emílio Ribas
Outcome results
None listed