Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
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.