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Corticosteroids Therapy on the Development of Interstitial Fibrosis in Patients With HIV Infection and Mild Pneumocystis Jirovecii Pneumonia (PCP)

2014-07-24 14:18:26 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Active Control, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pneumocystis Carinii Pneumonia

Intervention

Antibiotics only, Antibiotics + Corticosteroids, Corticosteroids + antibiotics

Location

George Washington University Medical Faculty Associates
Washington
District of Columbia
United States
20037

Status

Recruiting

Source

George Washington University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:18:26-0400

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Nonsusceptibility of bacteria to the action of the beta-lactam antibiotics. Mechanisms responsible for beta-lactam resistance may be degradation of antibiotics by BETA-LACTAMASES, failure of antibiotics to penetrate, or low-affinity binding of antibiotics to targets.

The prototype species of PNEUMOCYSTIS infecting the laboratory rat, Rattus norvegicus (RATS). It was formerly called Pneumocystis carinii f. sp. carinii. Other species of Pneumocystis can also infect rats.

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A species of PNEUMOCYSTIS infecting humans and causing PNEUMOCYSTIS PNEUMONIA. It also occasionally causes extrapulmonary disease in immunocompromised patients. Its former name was Pneumocystis carinii f. sp. hominis.

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