Pneumocystis Carinii Pneumonia Clinical Trial
Official title:
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.
To explore the effects of corticosteroid therapy on pulmonary fibrosis and potentially pneumothorax in patients with mild PCP (pO2 >70mmHg) combined with the standard of care treatment of antibiotic therapy.
Although the development of highly active anti-retroviral therapy has substantially reduced
the incidence of Pneumocystis jirovecii pneumonia (PCP) among HIV-infected individuals, PCP
remains one of the most common presenting opportunistic infection among this population. The
use of adjunctive corticosteroids in the treatment of patients with moderate to severe PCP
has resulted in a significant improvement in the development of respiratory failure and
mortality.
Past studies have demonstrated no clinical benefit in patients with mild disease (pO2>75
torr on room air). This may have been due to the fact that few patients with mild disease
develop either respiratory failure or die during the course of the acute illness so that a
statistical difference could not be demonstrated.
However, considering parameters other than mortality, there is some evidence to suggest that
patients with high pO2 concentrations benefit from adjunctive corticosteroids. PCP is
associated with the development of pulmonary fibrosis and this can have significant
consequences. Pathological studies have shown the development of interstitial fibrosis late
in the course of acute illness. Studies have documented the presence of diffuse interstitial
pneumonitis five months after the onset of acute illness. Therefore, patients with PCP
infection, regardless of their pO2 level on presentation may benefit from corticosteroid
therapy.
The current standard of care therapy for patients with PCP does not involve the addition of
corticosteroids to standard antibiotics in those patients with pO2>70 mmHG. This study
propose to conduct a randomized, prospective, un-blinded clinical trial to explore the
effects of corticosteroid therapy on pulmonary fibrosis in patients with mild PCP who are
admitted to the George Washington University Hospital.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00302341 -
DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP)
|
Phase 3 |