Pneumocystis Jerovici Pneumonia in Infants and Steroids

Pneumonia, Pneumocystis Jerovici Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149433
• Other study ID #: Pneumocystis and Steroids
• Status: Completed
• Phase: N/A
• First received: July 9, 2012
• Last updated: December 9, 2015
• Start date: May 2012
• Est. completion date: February 2015

Study information

• Verified date: December 2015
• Source: University of Malawi College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This is a double-blind randomized controlled trial assessing the efficacy of adjuvant corticosteroids in clinically diagnosed Pneumocystis jiroveci pneumonia in infants.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months to 6 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Pneumocystis
• Pneumonia, Pneumocystis Jerovici

Intervention

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.
• Placebo

Locations

Country	Name	City	State
Malawi	Queen Elizabeth Central Hospital	Blantyre

Sponsors (1)

Lead Sponsor	Collaborator
University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months	No
Secondary	Commencement of antiretroviral treatment	To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.	36 months	No
Secondary	6 month survival	To determine whether steroids significantly increase the number of patients that survive to 6 months following commencement of anti-retrovirals.	36 months	No
Secondary	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.	36 months	No