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Recruitment Status : Withdrawn (No patient completed protocol)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

Sponsor:

Information provided by (Responsible Party):

Gary Simon, George Washington University

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.

Condition or disease	Intervention/treatment	Phase
Pneumocystis Carinii Pneumonia	Drug: Antibiotics only Drug: Antibiotics + Corticosteroids Drug: Corticosteroids + antibiotics	Phase 4

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.

Study Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Pneumonia Steroids

Genetic and Rare Diseases Information Center resources: Pneumocystosis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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 Names: 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 Names: Prednisone Bactrim Pentamidine Atovaquone Primaquine/Clindamycin Trimethoprim/Dapsone

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Information from the National Library of Medicine

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

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

Publications:

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.

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.

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. 1992;5(7):726-31.

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.

Gallant JE, Chaisson RE, Moore RD. The effect of adjunctive corticosteroids for the treatment of Pneumocystis carinii pneumonia on mortality and subsequent complications. Chest. 1998 Nov;114(5):1258-63.

Nowak J. Late pulmonary changes in the course of infection with Pneumocystis carinii. Acta Med Pol. 1966;7(1):23-41.

Whitcomb ME, Schwarz MI, Charles MA, Larson PH. Interstitial fibrosis after Pneumocystis carinii pneumonia. Ann Intern Med. 1970 Nov;73(5):761-5.

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.

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.

Tumbarello M, Tacconelli E, Pirronti T, Cauda R, Ortona L. Pneumothorax in HIV-infected patients: role of Pneumocystis carinii pneumonia and pulmonary tuberculosis. Eur Respir J. 1997 Jun;10(6):1332-5.


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

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