Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

George Washington University (GW)

Status and phase: Withdrawn; Phase 4

Conditions: Pneumocystis Carinii Pneumonia

Treatments: Drug: Antibiotics only; Drug: Corticosteroids + antibiotics; Drug: Antibiotics + Corticosteroids

Study type: Interventional

Funder types: Other

Identifiers

NCT00636935

ARPCP001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

1

Experimental group

Description:

Antibiotic only therapy in patients with PCP and a pO2 of \> 70mmHg.

Treatment:

Drug: Antibiotics only

2

Experimental group

Description:

Antibiotics and Corticosteroid therapy in patients with PCP and pO2 \>70 mmHg.

Treatment:

Drug: Antibiotics + Corticosteroids

3

Active Comparator group

Description:

Standard of care therapy for patients with PCP and pO2 \< 70mmHg.

Treatment:

Drug: Corticosteroids + antibiotics