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This study has been withdrawn prior to enrollment.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

February 28, 2008
August 20, 2013
February 2008
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00636935 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pneumocystis Carinii Pneumonia
  • Drug: Antibiotics only
    Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
  • 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
  • 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
  • Experimental: 1
    Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
    Intervention: Drug: Antibiotics only
  • Experimental: 2
    Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
    Intervention: Drug: Antibiotics + Corticosteroids
  • Active Comparator: 3
    Standard of care therapy for patients with PCP and pO2 < 70mmHg.
    Intervention: Drug: Corticosteroids + antibiotics

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00636935
ARPCP001
No
George Washington University
George Washington University
Not Provided
Principal Investigator: Afsoon Roberts, M.D. George Washington University Medical Faculty Associates
George Washington University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP