Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2013-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

NCT04355247

Covid-19

UNKNOWN PHASE2

Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia

NCT04451174

COVID-19

TERMINATED PHASE3

Non Invasive Diagnosis of Pneumocystis Pneumonia

NCT03613025

Pneumocystis

COMPLETED NA

A Polymerase Chain Reaction (PCR) - Based Method to Improve Antibiotic Prescribing for Pneumonia

NCT00867841

Pneumonia

WITHDRAWN

Efficacy and Safety of Corticosteroids in Oxygen-dependent Patients With COVID-19 Pneumonia

NCT04359511

COVID-19

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pneumocystis Carinii Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type EXPERIMENTAL

Antibiotics only

Intervention Type DRUG

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

2

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

Group Type EXPERIMENTAL

Antibiotics + Corticosteroids

Intervention Type 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).

3

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

Group Type ACTIVE_COMPARATOR

Corticosteroids + antibiotics

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Antibiotics only

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

Intervention Type 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).

Intervention Type DRUG

Corticosteroids + antibiotics

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Prednisone Bactrim Pentamidine Atovaquone Primaquine/Clindamycin Trimethoprim/Dapsone Prednisone Bactrim Pentamidine Atovaquone Primaquine/Clindamycin Trimethoprim/Dapsone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No