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Sponsored by: |
George Washington University |
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Information provided by: | George Washington University |
ClinicalTrials.gov Identifier: | NCT00636935 |
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 |
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Pneumocystis Carinii Pneumonia |
Drug: Antibiotics only Drug: Antibiotics + Corticosteroids Drug: Corticosteroids + antibiotics |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Randomized, Non-Blinded Clinical Trial Examining the Effects of Oral Corticosteroids Therapy on the Development of Interstitial Fibrosis in Patients With HIV Infection and Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation. |
Estimated Enrollment: | 54 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg.
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Drug: Antibiotics only
Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
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2: Experimental
Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg.
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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).
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3: Active Comparator
Standard of care therapy for patients with PCP and pO2 < 70mmHg.
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Drug: Corticosteroids + antibiotics
Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
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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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Beverly D. Bentley, M.P.H. | 202-741-3399 | bbentley@gwu.mfa.edu |
United States, District of Columbia | |
George Washington University Medical Faculty Associates | Recruiting |
Washington, District of Columbia, United States, 20037 |
Principal Investigator: | Afsoon Roberts, M.D. | George Washington University Medical Faculty Associates |
Responsible Party: | George Washington University Department of Medicine Division of Infectious Diseases ( Afsoon Roberts, M.D. ) |
Study ID Numbers: | ARPCP001 |
Study First Received: | February 28, 2008 |
Last Updated: | March 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00636935 |
Health Authority: | United States: Institutional Review Board |
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 |
Prednisone Sexually Transmitted Diseases, Viral Clindamycin Trimethoprim Primaquine Clotrimazole Fibrosis Miconazole Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis Mycoses Respiratory Tract Infections Respiratory Tract Diseases Dapsone Pentamidine |
Retroviridae Infections Lung Diseases, Fungal Sulfamethoxazole Clindamycin-2-phosphate Pneumocystosis Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Folic Acid Virus Diseases Pneumocystis Infections Atovaquone HIV Infections Lung Diseases Sexually Transmitted Diseases |
Anti-Inflammatory Agents Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Renal Agents Hormones Antimalarials Anti-Bacterial Agents Antiparasitic Agents |
Therapeutic Uses Antifungal Agents RNA Virus Infections Immune System Diseases Antineoplastic Agents, Hormonal Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Glucocorticoids Pharmacologic Actions Protein Synthesis Inhibitors Lentivirus Infections Leprostatic Agents |