Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
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ClinicalTrials.gov Identifier: NCT00636935 |
Recruitment Status
:
Withdrawn
(No patient completed protocol)
First Posted
: March 17, 2008
Last Update Posted
: June 27, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pneumocystis Carinii Pneumonia | Drug: Antibiotics only Drug: Antibiotics + Corticosteroids Drug: Corticosteroids + antibiotics | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
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. |
Study Start Date : | February 2008 |
Estimated Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
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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Experimental: 2
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).
Other Names:
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Active Comparator: 3
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.
Other Names:
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- 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.

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636935
United States, District of Columbia | |
George Washington University Medical Faculty Associates | |
Washington, D.C., District of Columbia, United States, 20037 |
Principal Investigator: | Afsoon Roberts, M.D. | George Washington University Medical Faculty Associates |
Publications:
Responsible Party: | Gary Simon, Principal Investigator, George Washington University |
ClinicalTrials.gov Identifier: | NCT00636935 History of Changes |
Other Study ID Numbers: |
ARPCP001 |
First Posted: | March 17, 2008 Key Record Dates |
Last Update Posted: | June 27, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
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 Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Anti-Bacterial Agents Clindamycin Clindamycin palmitate Clindamycin phosphate Dapsone Trimethoprim, Sulfamethoxazole Drug Combination Antibiotics, Antitubercular |
Prednisone Primaquine Trimethoprim Pentamidine Atovaquone Anti-Infective Agents Antitubercular Agents Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Protein Synthesis Inhibitors |