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Pneumocystis Jerovici Pneumonia in Infants and Steroids

NCT ID: NCT02149433

Last Updated: 2015-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-02-28

Brief Summary

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

Detailed Description

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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

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Pneumonia, Pneumocystis Jerovici

Keywords

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Pneumocystis Jiroveci Steroids Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Prednisone versus 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

Group Type EXPERIMENTAL

Prednisone

Intervention Type 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.

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kamuzu University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Molyneux

Lecturer Paediatrics and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Newberry, MD

Role: PRINCIPAL_INVESTIGATOR

Paediatric Department, College of Medicine, University of Malawi

Elizabeth Molyneux, FRCPCH

Role: STUDY_DIRECTOR

Paediatric Department, College of Medicine, University of Malawi

Locations

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Queen Elizabeth Central Hospital

Blantyre, , Malawi

Site Status

Countries

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Malawi

Other Identifiers

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Pneumocystis and Steroids

Identifier Type: -

Identifier Source: org_study_id