Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

NCT00636935 | Withdrawn Phase 4

• 1 other identifier: ARPCP001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month, 3 months and 6 months after diagnosis

Study Arms (3)

1

EXPERIMENTAL

Antibiotic only therapy in patients with PCP and a pO2 of \> 70mmHg.

Drug: Antibiotics only

2

EXPERIMENTAL

Antibiotics and Corticosteroid therapy in patients with PCP and pO2 \>70 mmHg.

Drug: Antibiotics + Corticosteroids

3

ACTIVE COMPARATOR

Standard of care therapy for patients with PCP and pO2 \< 70mmHg.

Drug: Corticosteroids + antibiotics

Interventions

Antibiotics only DRUG

Antibiotic only for treatment for mild (pO2 \> 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.

1

Antibiotics + Corticosteroids DRUG

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).

Also known as: Prednisone, Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, Trimethoprim/Dapsone

2

Corticosteroids + antibiotics DRUG

Drugs will be prescribed per standard of care for patients with PCP and pO2 \< 70mmHg.

Also known as: Prednisone, Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, Trimethoprim/Dapsone

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (10)

• 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.

  PMID: 2233917 BACKGROUND

• 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.

  PMID: 2190515 BACKGROUND

• 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.

  PMID: 1613673 BACKGROUND

• 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.

  PMID: 2233916 BACKGROUND

• 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. doi: 10.1378/chest.114.5.1258.

  PMID: 9823998 BACKGROUND

• Nowak J. Late pulmonary changes in the course of infection with Pneumocystis carinii. Acta Med Pol. 1966;7(1):23-41. No abstract available.

  PMID: 5296368 BACKGROUND

• 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.

  PMID: 5312204 BACKGROUND

• 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.

  PMID: 1994791 BACKGROUND

• 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.

  PMID: 8438099 BACKGROUND

• 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. doi: 10.1183/09031936.97.10061332.

  PMID: 9192938 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; Pneumonia; Acquired Immunodeficiency Syndrome

Interventions

Anti-Bacterial Agents; Adrenal Cortex Hormones; Prednisone; Trimethoprim, Sulfamethoxazole Drug Combination; Pentamidine; Atovaquone; Primaquine; Clindamycin; Trimethoprim; Dapsone

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Benzamidines; Amidines; Naphthoquinones; Quinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Study Officials

• Afsoon Roberts, M.D.

  George Washington University Medical Faculty Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 17, 2008
• Study Start: February 1, 2008
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: June 27, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)