Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
Primary Purpose
Pneumocystis Carinii Pneumonia
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Antibiotics only
Antibiotics + Corticosteroids
Corticosteroids + antibiotics
Sponsored by
About this trial
This is an interventional treatment trial for Pneumocystis Carinii Pneumonia focused on measuring 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
Eligibility 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
Sites / Locations
- George Washington University Medical Faculty Associates
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
Standard of care therapy for patients with PCP and pO2 < 70mmHg.
Outcomes
Primary Outcome Measures
Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.
Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.
Secondary Outcome Measures
Full Information
NCT ID
NCT00636935
First Posted
February 28, 2008
Last Updated
June 23, 2017
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT00636935
Brief Title
Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
Official Title
Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No patient completed protocol
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Washington University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumocystis Carinii Pneumonia
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
Arm Title
2
Arm Type
Experimental
Arm Description
Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Standard of care therapy for patients with PCP and pO2 < 70mmHg.
Intervention Type
Drug
Intervention Name(s)
Antibiotics only
Intervention Description
Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
Intervention Type
Drug
Intervention Name(s)
Antibiotics + Corticosteroids
Other Intervention Name(s)
Prednisone, Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, Trimethoprim/Dapsone
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Corticosteroids + antibiotics
Other Intervention Name(s)
Prednisone, Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, Trimethoprim/Dapsone
Intervention Description
Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
Primary Outcome Measure Information:
Title
Changes in pulmonary function testing and DLCO measurements in patients with PCP and pO2 > 70 mmHg.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afsoon Roberts, M.D.
Organizational Affiliation
George Washington University Medical Faculty Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University Medical Faculty Associates
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
2233917
Citation
Bozzette SA, Sattler FR, Chiu J, Wu AW, Gluckstein D, Kemper C, Bartok A, Niosi J, Abramson I, Coffman J, et al. A controlled trial of early adjunctive treatment with corticosteroids for Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. California Collaborative Treatment Group. N Engl J Med. 1990 Nov 22;323(21):1451-7. doi: 10.1056/NEJM199011223232104.
Results Reference
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PubMed Identifier
2190515
Citation
Montaner JS, Lawson LM, Levitt N, Belzberg A, Schechter MT, Ruedy J. Corticosteroids prevent early deterioration in patients with moderately severe Pneumocystis carinii pneumonia and the acquired immunodeficiency syndrome (AIDS). Ann Intern Med. 1990 Jul 1;113(1):14-20. doi: 10.7326/0003-4819-113-1-14.
Results Reference
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PubMed Identifier
1613673
Citation
Nielsen TL, Eeftinck Schattenkerk JK, Jensen BN, Lundgren JD, Gerstoft J, van Steenwijk RP, Bentsen K, Frissen PH, Gaub J, Orholm M, et al. Adjunctive corticosteroid therapy for Pneumocystis carinii pneumonia in AIDS: a randomized European multicenter open label study. J Acquir Immune Defic Syndr (1988). 1992;5(7):726-31.
Results Reference
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PubMed Identifier
2233916
Citation
Gagnon S, Boota AM, Fischl MA, Baier H, Kirksey OW, La Voie L. Corticosteroids as adjunctive therapy for severe Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome. A double-blind, placebo-controlled trial. N Engl J Med. 1990 Nov 22;323(21):1444-50. doi: 10.1056/NEJM199011223232103.
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PubMed Identifier
9823998
Citation
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PubMed Identifier
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Citation
Nowak J. Late pulmonary changes in the course of infection with Pneumocystis carinii. Acta Med Pol. 1966;7(1):23-41. No abstract available.
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PubMed Identifier
5312204
Citation
Whitcomb ME, Schwarz MI, Charles MA, Larson PH. Interstitial fibrosis after Pneumocystis carinii pneumonia. Ann Intern Med. 1970 Nov;73(5):761-5. doi: 10.7326/0003-4819-73-5-761. No abstract available.
Results Reference
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PubMed Identifier
1994791
Citation
Sepkowitz KA, Telzak EE, Gold JW, Bernard EM, Blum S, Carrow M, Dickmeyer M, Armstrong D. Pneumothorax in AIDS. Ann Intern Med. 1991 Mar 15;114(6):455-9. doi: 10.7326/0003-4819-114-6-455.
Results Reference
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PubMed Identifier
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Citation
Coker RJ, Moss F, Peters B, McCarty M, Nieman R, Claydon E, Mitchell D, Harris JR. Pneumothorax in patients with AIDS. Respir Med. 1993 Jan;87(1):43-7. doi: 10.1016/s0954-6111(05)80312-9.
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Citation
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Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
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