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Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

This study has been withdrawn prior to enrollment.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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00636935

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


Responsible Party: George Washington University Identifier: NCT00636935     History of Changes
Other Study ID Numbers: ARPCP001
Study First Received: February 28, 2008
Last Updated: August 20, 2013

Keywords provided by George Washington University:
Pneumocystis jirovecii Pneumonia
Corticosteroid Therapy
Pulmonary Function Testing
Human Immunodeficiency Virus
Viral Load

Additional relevant MeSH terms:
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Pneumocystis Infections
Anti-Bacterial Agents
Trimethoprim, Sulfamethoxazole Drug Combination
Clindamycin palmitate
Clindamycin phosphate
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimalarials processed this record on May 22, 2017