Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

This study has been withdrawn prior to enrollment.
(No patient completed protocol)
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT00636935
First received: February 28, 2008
Last updated: August 20, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pneumocystis Carinii Pneumonia
Drug: Antibiotics only
Drug: Antibiotics + Corticosteroids
Drug: Corticosteroids + antibiotics
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.

Resource links provided by NLM:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg. [ Time Frame: 1 month, 3 months and 6 months after diagnosis ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2008
Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
Drug: Antibiotics only
Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
Experimental: 2
Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
Drug: Antibiotics + Corticosteroids
Prednisone 40mg orally twice daily for 11 days, followed by 40mg once daily for 5 days, followed by 20mg once daily for 5 days and antibiotics (Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone).
Other Names:
  • Prednisone
  • Bactrim
  • Pentamidine
  • Atovaquone
  • Primaquine/Clindamycin
  • Trimethoprim/Dapsone
Active Comparator: 3
Standard of care therapy for patients with PCP and pO2 < 70mmHg.
Drug: Corticosteroids + antibiotics
Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
Other Names:
  • Prednisone
  • Bactrim
  • Pentamidine
  • Atovaquone
  • Primaquine/Clindamycin
  • Trimethoprim/Dapsone

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636935

Locations
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: Afsoon Roberts, M.D. George Washington University Medical Faculty Associates
  More Information

Publications:
Sepkowitz KA, Telzak EE, Gold JW, et al Pneumothorax in Patients with AIDS. Annal of Internal Medicine 1991, 114:455-459

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT00636935     History of Changes
Other Study ID Numbers: ARPCP001
Study First Received: February 28, 2008
Last Updated: August 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
Pneumocystis jirovecii Pneumonia
Corticosteroid Therapy
HIV
Pneumonia
Pulmonary Function Testing
Antibiotics
Prednisone
Human Immunodeficiency Virus
CD4
CD8
Viral Load
Bactrim
Pentamidine
Atovaquone
Primaquine/Clindamycin
Trimethoprim/Dapsone

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Anti-Bacterial Agents
Clindamycin
Clindamycin-2-phosphate
Dapsone
Antibiotics, Antitubercular
Pentamidine
Primaquine
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Atovaquone
Prednisone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on July 24, 2014