Pneumocystis Carinii PneumoniaPhase 4NCT00636935
Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)
A Phase 4 study testing Antibiotics only, Antibiotics + Corticosteroids and Corticosteroids + antibiotics in people with Pneumocystis Carinii Pneumonia, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumocystis Carinii Pneumonia
- What is being tested?
- Antibiotics only, Antibiotics + Corticosteroids and Corticosteroids + antibiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Aug 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.
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.
Read the 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.
- Conditions
- Pneumocystis Carinii Pneumonia
- Being tested
- Antibiotics only, Antibiotics + Corticosteroids, Corticosteroids + antibiotics
- 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
- Medical subject headings
- Pneumonia, Pneumocystis, Pneumonia, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics onlyDrug
Antibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone.
Antibiotics + CorticosteroidsDrug
Also called Prednisone, Bactrim, Pentamidine, Atovaquone
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).
Corticosteroids + antibioticsDrug
Also called Prednisone, Bactrim, Pentamidine, Atovaquone
Drugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Antibiotic only therapy in patients with PCP and a pO2 of > 70mmHg. Receives: Drug: Antibiotics only |
| 2 | Experimental | Antibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg. Receives: Drug: Antibiotics + Corticosteroids |
| 3 | Active comparator | Standard of care therapy for patients with PCP and pO2 < 70mmHg. Receives: Drug: Corticosteroids + antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months and 6 months after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2013 (estimated)
- Study completionAug 2013
Why it stopped: No patient completed protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pneumocystis Carinii PneumoniaStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Simon, George Washington University
- Investigators
- Afsoon Roberts, M.D., Principal investigator, George Washington University Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636935
- Sponsor's protocol ID
- ARPCP001
- Status last verified
- Jun 2017
- First submitted
- 28 Feb 2008
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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. doi: 10.1056/NEJM199011223232104.
PubMed 2233917Montaner 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.
PubMed 2190515Nielsen 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.
PubMed 1613673Gagnon 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.
PubMed 2233916Gallant 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.
PubMed 9823998Nowak J. Late pulmonary changes in the course of infection with Pneumocystis carinii. Acta Med Pol. 1966;7(1):23-41. No abstract available.
PubMed 5296368Whitcomb 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.
PubMed 5312204Sepkowitz 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.
PubMed 1994791Coker 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.
PubMed 8438099Tumbarello 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.
PubMed 9192938
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Corticosteroids Therapy and Interstitial Fibrosis in Patients With Pneumocystis Jirovecii Pneumonia (PCP) and pO2 of >70 at Presentation.
- ClinicalTrials.gov ID
- NCT00636935
- Acronym / sponsor ID
- ARPCP001
- Conditions
- Pneumocystis Carinii Pneumonia
- Keywords
- Pneumocystis jirovecii Pneumonia, Corticosteroid Therapy, HIV, Pneumonia, Pulmonary Function Testing, Antibiotics, Prednisone, Human Immunodeficiency Virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient completed protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Antibiotics onlyAntibiotic only therapy in patients with PCP and a pO2 of > 70mmHg. |
| 2 | Experimental | Drug: Antibiotics + CorticosteroidsAntibiotics and Corticosteroid therapy in patients with PCP and pO2 >70 mmHg. |
| 3 | Active comparator | Drug: Corticosteroids + antibioticsStandard of care therapy for patients with PCP and pO2 < 70mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotics onlyAntibiotic only for treatment for mild (pO2 > 70mmHg) PCP. Antibiotic Treatment with Bactrim, Pentamidine, Atovaquone, Primaquine/Clindamycin, or Trimethoprim/Dapsone. | Drug | 1 |
| Antibiotics + CorticosteroidsAlso: Prednisone, Bactrim, Pentamidine, AtovaquonePrednisone 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). | Drug | 2 |
| Corticosteroids + antibioticsAlso: Prednisone, Bactrim, Pentamidine, AtovaquoneDrugs will be prescribed per standard of care for patients with PCP and pO2 < 70mmHg. | Drug | 3 |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Background: PubMed 2233917Bozzette 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.
- Background: PubMed 2190515Montaner 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.
- Background: PubMed 1613673Nielsen 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.
- Background: PubMed 2233916Gagnon 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.
- Background: PubMed 9823998Gallant 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.
- Background: PubMed 5296368Nowak J. Late pulmonary changes in the course of infection with Pneumocystis carinii. Acta Med Pol. 1966;7(1):23-41. No abstract available.
- Background: PubMed 5312204Whitcomb 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.
- Background: PubMed 1994791Sepkowitz 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.
- Background: PubMed 8438099Coker 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.
- Background: PubMed 9192938Tumbarello 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.
- Individual participant dataSharing planned: No
Related trials for Pneumocystis Carinii Pneumonia
Not yet recruitingPhase 3
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
Pneumocystis Jirovecii Pneumonia
RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Pneumocystis Pneumonia, Pneumocystis Jirovecii Infection
Not yet recruitingObservational study
TMP-SMX for Non-HIV PCP: A Prospective Multicenter Study
Pneumocystis Jirovecii Pneumonia in Non-HIV Patients
RecruitingObservational study
Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score
Pneumonia, Fungal Pneumonia
Not yet recruiting
Study on the Impact of Decolonization Treatment of Pneumocystis Jirovecii on the Frequency of Acute Exacerbation in COPD
Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afsoon Roberts, M.D. principal investigator
George Washington University Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotics only, Antibiotics + Corticosteroids and Corticosteroids + antibiotics in people with Pneumocystis Carinii Pneumonia, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00636935, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2017.