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Clinical Trials

MainTitle

Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

This study has been withdrawn
Sponsor
George Washington University


Information provided by (Responsible Party)
Gary Simon, George Washington University

ClinicalTrials.gov Identifier
NCT00636935

First received: February 28, 2008
Last updated: June 23, 2017
Last Verified: June 2017
History of Changes
Purpose

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.

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 Name:
  • 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 Name:
  • 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

Eligibility

Ages Eligible for Study: 18 Years and older  
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

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, 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

More Information


Responsible Party: Gary Simon, Principal Investigator, George Washington University  
ClinicalTrials.gov Identifier: NCT00636935   History of Changes  
Other Study ID Numbers: ARPCP001  
Study First Received: February 28, 2008  
Last Updated: June 23, 2017  
Individual Participant Data    
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
Anti-Bacterial Agents
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Dapsone
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Prednisone
Primaquine
Trimethoprim
Pentamidine
Atovaquone

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.