This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
78
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.
Queen Elizabeth Central Hospital
Blantyre, Malawi
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.
Time frame: 36 months
Commencement of antiretroviral treatment
To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.
Time frame: 36 months
6 month survival
To determine whether steroids significantly increase the number of patients that survive to 6 months following commencement of anti-retrovirals.
Time frame: 36 months
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.
Time frame: 36 months
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