We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

This study has been withdrawn prior to enrollment.
(No patient completed protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636935
First Posted: March 17, 2008
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gary Simon, George Washington University
  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: None (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 Gary Simon, 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 ]
    Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636935


Locations
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, D.C., 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:

Responsible Party: Gary Simon, Principal Investigator, George Washington University
ClinicalTrials.gov Identifier: NCT00636935     History of Changes
Other Study ID Numbers: ARPCP001
First Submitted: February 28, 2008
First Posted: March 17, 2008
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gary Simon, 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 palmitate
Clindamycin phosphate
Dapsone
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Prednisone
Primaquine
Trimethoprim
Pentamidine
Atovaquone
Anti-Infective Agents
Antitubercular Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protein Synthesis Inhibitors