Pneumocystis Jerovici Pneumonia in Infants and Steroids

Not Applicable

Completed

• Conditions: Pneumonia, Pneumocystis Jerovici
• Interventions: Drug: Prednisone; Drug: Placebo

• Registration Number: NCT02149433
• Lead Sponsor: Kamuzu University of Health Sciences

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-09
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Primary Completion: 2014-08
• Study Completion: 2015-02
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2015-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prednisone versus placebo	Placebo	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
Prednisone versus placebo	Prednisone	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

Primary Outcome Measures

Name	Time	Method
Reduction in inpatient mortality by 20%.	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.

Secondary Outcome Measures

Name	Time	Method
6 month survival	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)	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.
Commencement of antiretroviral treatment	36 months	To determine whether steroids significantly increase the number of patients that successfully commence anti-retroviral treatment.

Trial Locations

Locations (1)

Queen Elizabeth Central Hospital; 🇲🇼 Blantyre, Malawi