- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02149433
Pneumocystis Jerovici Pneumonia in Infants and Steroids
December 9, 2015 updated by: Elizabeth Molyneux, Kamuzu University of Health Sciences
Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi
This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study aims to determine whether the early administration of adjuvant corticosteroids in addition to high dose oral Co-trimoxazole reduces mortality amongst infants aged 2-6 months with vertically acquired HIV and clinically diagnosed Pneumocystis jiroveci pneumonia.
Infants will be randomized to receive either a steroid regime of oral prednisolone at 2 mg/kg for 7 days, then 1 mg/kg for 7 days, then 0.5mg/kg for 7 days for a total of 21 days or placebo.
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Blantyre, Malawi
- Queen Elizabeth Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 6 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive infants with HIV and clinical features of Pneumocystis jiroveci pneumonia who require oxygen (oxygen saturations in air < 90%).
- Clinical diagnosis of Pneumocystis jiroveci pneumonia will be made by one of the study investigators. All infants must be HIV ELISA positive or exposed, have an oxygen requirement (saturations on air < 90%) and have severe respiratory distress and cough. They may also have a low grade fever, clear chest or diffuse signs on auscultation and features suggestive of Pneumocystis jiroveci infection on chest radiography.
Exclusion Criteria:
- Previous known allergy or hypersensitivity or other contraindication to corticosteroids or co-trimoxazole.
- Previous treatment for suspected Pneumocystis jiroveci pneumonia or a delay starting steroids for greater than 24 hours after starting high dose co-trimoxazole.
- Patients who are not exposed to HIV.
- Infants with known preexisting active pulmonary or cardiac disease.
- Patients who do not live within the Blantyre district and who are unable to attend follow up at QECH.
- Infants whose parents or guardians refuse consent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prednisone versus placebo
Prednisone 2mg/kg orally once a day x 7 days, 1 mg/kg orally once a day x 7 days and then 0.5 mg/kg orally once a day x 7 days
|
The steroid regime will be oral prednisone at 2 mg/kg for 7 days, then 1 mg/kg for 7 days, then 0.5mg/kg for 7 days for a total of 21 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in inpatient mortality by 20%.
Time Frame: 36 months
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To determine whether the addition of oral Prednisolone to standard treatment reduces inpatient mortality by 20% in patients aged 2-6 months with clinical PJP pneumonia.
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36 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Commencement of antiretroviral treatment
Time Frame: 36 months
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To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.
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36 months
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6 month survival
Time Frame: 36 months
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To determine whether steroids significantly increase the number of patients that survive to 6 months following commencement of anti-retrovirals.
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36 months
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Morbidity (days in hospital and days on oxygen)
Time Frame: 36 months
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To determine whether steroids significantly alter morbidity as determined by number of days spent in hospital as an inpatient and number of days on oxygen.
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36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura Newberry, MD, Paediatric Department, College of Medicine, University of Malawi
- Study Director: Elizabeth Molyneux, FRCPCH, Paediatric Department, College of Medicine, University of Malawi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
February 1, 2015
Study Registration Dates
First Submitted
July 9, 2012
First Submitted That Met QC Criteria
May 28, 2014
First Posted (ESTIMATE)
May 29, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
December 11, 2015
Last Update Submitted That Met QC Criteria
December 9, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisone
Other Study ID Numbers
- Pneumocystis and Steroids
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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