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Slow initial beeta-lactam infusion, and high-dose paracetamol to improve the prognosis of childhood bacterial meningitis, especially of pneumococcal meningitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN62824827
Enrollment
750
Registered
2005-10-04
Start date
2005-06-27
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood bacterial meningitis Infections and Infestations Meningitis

Interventions

All children will receive cefotaxime 250 mg/kg/day for seven days, except salmonella meningitis for which antimicrobial treatment should last for 14 days or more. Regardless of etiology, the children

Sponsors

Luanda Hospital (Angola)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [Added as of 22/01/2008: All children aged at least 2 months with suspected or confirmed bacterial meningitis.] Diagnosis: BM is defined as a case with: 1. Positive CSF culture, or 2. Symptoms and signs compatible with bacterial meningitis, and positive blood culture, or 3. Symptoms and signs compatible with bacterial meningitis, and at least two of the following criteria: 3.1. CSF pleocytosis more than or equal to 100 cells/mm^3 3.2. A positive Gram-stain result 3.3. Positive latex agglutination test 3.4. Serum C-Reactive Protein (CRP) more than or equal to 40 mg/l, or 4. Symptoms and signs compatible with bacterial meningitis, and positive CSF antigen detection by Polymerase Chain Reaction (PCR)

Exclusion criteria

Exclusion criteria: The exclusion criteria comprise the age less than two months, trauma, or relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome, meningitis), previous hearing impairment if known, and immunosuppression, except Human Immunodeficiency Virus (HIV) infection.

Design outcomes

Primary

MeasureTime frame
Current primary endpoints as of 22/01/2008: 1. Death (measuring the exact time from institution of antimicrobial) OR severe neurological sequelae (blindness, quadriplegia, hydrocephalus requiring a shunt, or severe psychomotor retardation) at discharge 2. Profound hearing loss (more than 80 dB in both ears) at discharge Previous primary endpoints: 1. Death (measuring the exact time from institution of antimicrobial) 2. Severe neurological sequelae (blindness, quadriplegia, hydrocephalus requiring a shunt, or severe psychomotor retardation) 3. Profound hearing loss (more than 80 dB in both ears), as found at discharge from hospital and dismal outcome denotes death, severe neurological sequelae and/or profound hearing loss. Because severe neurological sequelae and death may form a continuum, their combination is taken as a composite endpoint. Various patient characteristics are taken into account as covariates, those being essentially the age, etiology (pneumococcus, Hib, meningococcus, other agents, and unidentified etiology), blood hemoglobin level, potential HIV- and/or malaria-infection, and the presenting status. This is graded by Glasgow Coma Scale (adjusted for age), the Blantyre Coma Scale, and the Herson-Todd Score. Also blood hemoglobin concentration will be related to the outcome, which is assessed with the modified Glasgow Outcome Scale.

Secondary

MeasureTime frame
Current secondary endpoints as of 22/01/2008: 1. Death or any audiological or any neurological sequelae: any neurological sequelae are, in addition to severe neurological sequelae : hemiparesis, monoparesis moderate psychomotor retardation, or ataxia. Psychomotor retardation is graded by (according to the Denver-II developmental screening test). Hearing is deemed impaired if a threshold of 40 dB remains unrecognized by the better ear, the cut-off levels for moderate and severe hearing impairment being 60 dB and 80 dB, respectively 2. Glasgow Outcome Scale 3. Potential differences in the indices of inflammation such as serum C-reactive protein (CRP) will also be examined Previous secondary endpoints: The secondary endpoints comprise any audiological or neurological sequelae (according to the Denver-II developmental screening test). Hearing is deemed impaired if a threshold of 40 dB is not recognized by the better ear. The cut-off levels for moderate and severe hearing impairment are 60 dB and 80 dB, respectively. Potential differences in the indices of inflammation such as serum C-Reactive Protein (CRP) will also be examined.

Countries

Angola

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 29, 2026