Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV Infection,
- •Hospital admission for suspected PCP,
- •Confirmatory test for PCP (bronchoscopy with bronchoalveolar lavage), pO2>70 mmHg or pO2<70 mmHg while breathing room air,
- •18 years or older
排除标准
- •Contraindications to corticosteroid therapy,
- •Unable and or unwilling to perform PFTS or to return for follow-up evaluations,
- •Underlying lung disease such as emphysema, untreated active tuberculosis, Uncontrolled diabetes (fasting glucose > 250 mg/dL,
- •Uncontrolled hypertension (160/95 mmHg),
- •Pregnancy
研究组 & 干预措施
1
Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
干预措施: Antibiotics only (Drug)
2
Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
干预措施: Antibiotics + Corticosteroids (Drug)
3
Standard of care therapy for patients with PCP and pO2 < 70mmHg.
干预措施: Corticosteroids + antibiotics (Drug)
结局指标
主要结局
Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.
时间窗: 1 month, 3 months and 6 months after diagnosis
Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 \> 70 mmHg.
次要结局
未报告次要终点
研究者
Gary Simon
Principal Investigator
George Washington University
