Clinical trial NCT02149433: Pneumocystis Jerovici Pneumonia in Infants and Steroids
Official title: Early Steroid Use in Infants With Clinical Pneumocystis Jiroveci Pneumonia (PCP) in the Queen Elizabeth Central Hospital, Blantyre, Malawi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumonia, Pneumocystis Jerovici
Keywords: Pneumocystis Jiroveci
Steroids
Infants
Lead sponsor: Kamuzu University of Health Sciences
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 78
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in inpatient mortality by 20%.
timeFrame: 36 months
Secondary outcomes:
measure: Commencement of antiretroviral treatment
timeFrame: 36 months
measure: 6 month survival
timeFrame: 36 months
measure: Morbidity (days in hospital and days on oxygen)
timeFrame: 36 months
Other outcomes:
Locations:
city: Blantyre
country: Malawi
facility: Queen Elizabeth Central Hospital
Study officials:
affiliation: Paediatric Department, College of Medicine, University of Malawi
name: Laura Newberry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Paediatric Department, College of Medicine, University of Malawi
name: Elizabeth Molyneux, FRCPCH
role: STUDY_DIRECTOR
References: