Pneumocystis Jerovici Pneumonia in Infants and Steroids

NCT02149433 | Completed DMC

• 1 other identifier: Pneumocystis and Steroids
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pneumonia, Pneumocystis Jerovici

Keywords

Pneumocystis Jiroveci; Steroids; Infants

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Commencement of antiretroviral treatment

  36 months

• 6 month survival

  36 months

• Morbidity (days in hospital and days on oxygen)

  36 months

Study Arms (1)

Prednisone versus placebo

EXPERIMENTAL

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

Drug: Prednisone; Drug: Placebo

Interventions

Prednisone DRUG

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.

Prednisone versus placebo

Placebo DRUG

Prednisone versus placebo

Eligibility Criteria

• Age: 2 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kamuzu University of Health Sciences: lead

Study Sites (1)

Queen Elizabeth Central Hospital

Blantyre, Malawi

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Laura Newberry, MD

  Paediatric Department, College of Medicine, University of Malawi

  PRINCIPAL INVESTIGATOR

• Elizabeth Molyneux, FRCPCH

  Paediatric Department, College of Medicine, University of Malawi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Paediatrics and Professor

Study Record Dates

• First Submitted: July 9, 2012
• First Posted: May 29, 2014
• Study Start: May 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: February 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

MA (1)