Back to resultsPneumocystis Jerovici Pneumonia in Infants and Steroids
Primary Purpose
Pneumonia, Pneumocystis Jerovici
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Prednisone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia, Pneumocystis Jerovici focused on measuring Pneumocystis Jiroveci, Steroids, Infants
Eligibility Criteria
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.
Sites / Locations
- Queen Elizabeth Central Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prednisone versus placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Reduction in inpatient mortality by 20%.
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.
Secondary Outcome Measures
Commencement of antiretroviral treatment
To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.
6 month survival
To determine whether steroids significantly increase the number of patients that survive to 6 months following commencement of anti-retrovirals.
Morbidity (days in hospital and days on oxygen)
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.
Full Information
NCT ID
NCT02149433
First Posted
July 9, 2012
Last Updated
December 9, 2015
Sponsor
Kamuzu University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02149433
Brief Title
Pneumocystis Jerovici Pneumonia in Infants and Steroids
Official Title
Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kamuzu University of Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Jerovici
Keywords
Pneumocystis Jiroveci, Steroids, Infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisone versus placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduction in inpatient mortality by 20%.
Description
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.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Commencement of antiretroviral treatment
Description
To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.
Time Frame
36 months
Title
6 month survival
Description
To determine whether steroids significantly increase the number of patients that survive to 6 months following commencement of anti-retrovirals.
Time Frame
36 months
Title
Morbidity (days in hospital and days on oxygen)
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Newberry, MD
Organizational Affiliation
Paediatric Department, College of Medicine, University of Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Molyneux, FRCPCH
Organizational Affiliation
Paediatric Department, College of Medicine, University of Malawi
Official's Role
Study Director
Facility Information:
Facility Name
Queen Elizabeth Central Hospital
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Learn more about this trial
Pneumocystis Jerovici Pneumonia in Infants and Steroids
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