Bacterial Meningitis Clinical Trial
— GLYIPOfficial title:
Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis - A Prospective, Randomized, and Double-Blind Clinical Study Using a Two-by-Two Factorial Design
Bacterial meningitis remains a significant cause of morbidity and mortality in children,
especially in countries with limited resources. Efforts to improve the grim outcome have
included altering the first line antibiotic therapy, controlling seizures and managing
fluids more carefully. Adjuvant therapy of steroids has been used with limited success in
children in the West and with no proven value in Malawi and other resource constrained
settings. Glycerol has been used to reduce brain oedema in neurosurgery and it has recently
been shown to reduce morbidity in childhood meningitis in South America. Paracetamol in a
high dosage has been shown to reduce inflammation and cytokine levels in septicaemia with
improved outcomes in adults.
In Malawi the investigators have tried adjuvant steroids with no improvement in outcome of
childhood meningitis. They have recently concluded a study of ceftriaxone which has shown no
improvement in mortality though there is less hearing loss than with chloramphenicol and
benzyl penicillin.
Following the encouraging results of the Childhood South American Study it is important to
assess the use of adjuvant glycerol in children in the investigators' setting. Paracetamol
is routinely used in meningitis because of the accompanying fever and headache. This is an
opportunity to study its place as adjuvant therapy more carefully than has previously been
done.
The investigators propose a prospective, randomized, double blind 2 by 2 factorial designed
study to assess the advantage of ceftriaxone (antibiotic) given with paracetamol and
glycerol in combination, singly or with neither adjuvant therapy in childhood bacterial
meningitis.
Status | Completed |
Enrollment | 466 |
Est. completion date | March 2012 |
Est. primary completion date | March 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Months to 15 Years |
Eligibility |
Inclusion Criteria: - All children aged = 2 months, admitted to Queen Elizabeth Hospital, Blantyre, Malawi, with possible or confirmed acute bacterial meningitis Exclusion Criteria: - Age less than two months - Trauma - Relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome) - Previous permanent hearing loss (not conductive hearing loss) if known - Immunosuppression except HIV infection. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malawi | College of Medicine, Queen Elizabeth Central Hospital | Blantyre |
Lead Sponsor | Collaborator |
---|---|
University of Malawi College of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary end points are death, severe neurological sequelae, hearing loss. | 2008-2011 | No | |
Secondary | Secondary end points are audiological or neurological sequelae (according to the Denver-II developmental screening test). | 2008-2011 | No |
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