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Sponsored by: |
University of Malawi College of Medicine |
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Information provided by: | University of Malawi College of Medicine |
ClinicalTrials.gov Identifier: | NCT00619203 |
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.
Condition | Intervention | Phase |
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Bacterial Meningitis |
Drug: Glycerol and paracetamol Drug: Paracetamol Drug: Placebo Drug: Paracetamol and glycerol Drug: Glycerol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official 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 |
Estimated Enrollment: | 750 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Two active ingredients
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Drug: Glycerol and paracetamol
glycerol by mouth (po) 1.5ml/kg max 25 ml/dose x 6 hourly x 8 doses paracetamol PR 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 35 mg/kg po first dose, then 20 mg/kg 6 hourly x 7 paracetamol 1.5 ml/kg max 25 ml/dose 6 hourly x 8 doses |
B: Active Comparator
One active ingredient
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Drug: Paracetamol
paracetamol 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses
Drug: Glycerol
glycerol 1.5 ml/kg /dose 6 hourly x 8 max dose = 25ml
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C: Active Comparator
One (other) active ingredient
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Drug: Paracetamol
paracetamol po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
Drug: Paracetamol
po 35 mg/kg first dose, then 20 mg/kg 6 hourly x 7 doses plus placebo suppository
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D: Placebo Comparator |
Drug: Placebo
2 placebos, one po, one suppository
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Ages Eligible for Study: | 2 Months to 15 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
College of Medicine, Queen Elizabeth Central Hospital | Recruiting |
Blantyre, Malawi, 3 | |
Contact: Elizabeth M Molyneux, FRCPCH 265 1 873 198 emolyneux@malawi.net | |
Contact: E Borgstein, FRCS 265 1871 911 eborgstein@medcol.mw | |
Principal Investigator: Elizabeth M Molyneux, FRCPCH |
Responsible Party: | College of Medicine, Malawi ( Prof. Elizabeth Molyneux ) |
Study ID Numbers: | P.03/07/499 |
Study First Received: | February 7, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00619203 |
Health Authority: | Malawi: National Health Sciences Research Committee |
Bacterial meningitis glycerol high dose paracetamol children |
Bacterial Infections Glycerol Bacterial meningitis Central Nervous System Infections |
Meningitis, Bacterial Central Nervous System Diseases Acetaminophen Meningitis |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs Nervous System Diseases Central Nervous System Bacterial Infections |
Peripheral Nervous System Agents Analgesics Protective Agents Cryoprotective Agents Central Nervous System Agents Pharmacologic Actions |