NCT02149433

Pneumocystis Jerovici Pneumonia in Infants and Steroids

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Kamuzu University of Health Sciences · Academic / Other
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Pneumocystis Jerovici

Interventions

Type	Name	Description
DRUG	Prednisone	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.
DRUG	Placebo

Timeline

• Start date: 2012-05-01
• Primary completion: 2014-08-01
• Completion: 2015-02-01
• First posted: 2014-05-29
• Last updated: 2015-12-11

Locations

1 site across 1 country: Malawi