Clinical Trial: Pneumocystis Jerovici Pneumonia in Infants and Steroids

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi

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 Summary: 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.
Sponsor: University of Malawi College of Medicine

Current Primary Outcome: Reduction in inpatient mortality by 20%. [ Time Frame: 36 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Commencement of antiretroviral treatment [ Time Frame: 36 months ]
    To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.
  • 6 month survival [ Time Frame: 36 months ]
    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) [ Time Frame: 36 months ]
    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.


Original Secondary Outcome: Same as current

Information By: University of Malawi College of Medicine

Dates:
Date Received: July 9, 2012
Date Started: May 2012
Date Completion:
Last Updated: December 9, 2015
Last Verified: December 2015