Withdrawn

Phase 3
Age: 28Days - 2Years
All Genders
ID00000741

A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Pediatric AIDS Patients

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

N/A

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

U

Upjohn

Collaborating Sponsor

AI-Summary

What this Trial Is About

To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study.

CONDITIONS

Official Title

The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Children With AIDS

Who Can Participate

Age: 28Days - 2Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Recombinant erythropoietin and any FDA-approved cytokine for management of anemia.
  • Antiretroviral agents.

Patients must have:

  • Documented HIV infection.
  • PCP.
  • No more than 36 hours of prior primary therapy for confirmed or presumed PCP.

Prior Medication:

Allowed:

  • Up to 35 hours of primary therapy for confirmed or presumed PCP.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

  • Demonstrated intolerance to steroids.
  • Requirement for steroids at greater than physiological doses for other medical conditions.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 6 locations

1

UCSD Med Ctr / Pediatrics / Clinical Sciences

La Jolla, California, United States, 920930672

Status Unknown

2

Chicago Children's Memorial Hosp

Chicago, Illinois, United States, 606143394

Status Unknown

3

St Louis Univ School of Medicine

St Louis, Missouri, United States, 63104

Status Unknown

4

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

5

Columbia Presbyterian Med Ctr

New York, New York, United States, 10032

Status Unknown

6

Duke Univ Med Ctr

Durham, North Carolina, United States, 277103499

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Consensus statement on the use of corticosteroids as adjunctive therapy for pneumocystis pneumonia in the acquired immunodeficiency syndrome.

National Institutes of Health-University of California Expert Panel for Corticosteroids as Adjunctive Therapy for Pneumocystis Pneumonia

https://pubmed.ncbi.nlm.nih.gov/2136587