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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01540838 |
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Date of registration:
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23/02/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Slow Initial ß-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis
INFU/PARA |
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Scientific title:
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Slow Initial ß-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis, Especially of Pneumococcal Meningitis, in Angola. |
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Date of first enrolment:
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February 2012 |
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Target sample size:
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375 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01540838 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Angola
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Contacts
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Name:
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Heikki O Peltola, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Childrens Hospital of Helsinki University Central Hospital |
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Key inclusion & exclusion criteria
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Eligibility criteria:
The study entry is assessed for all children at age 2 months - 15 years who present at
these centers with the symptoms and signs suggestive of bacterial meningitis (BM), and to
whom lumbar puncture is performed.
Inclusion criteria:
All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram
staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled
in the study.
Participants: Exclusion criteria
Exclusion criteria:
1. Trauma, or relevant underlying illness such as intracranial shunt, previous
neurological abnormality (cerebral palsy, Down's syndrome, meningitis)
2. Previous hearing impairment (if known)
3. Immunosuppression, except HIV infection
4. More than one parenteral dose of a pretreatment antimicrobial. Children with oral
antimicrobials are included, this information being marked in the FOLLOW-UP sheet.
5. Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be
included in intention-to-treat (ITT) analysis)
6. Known hepatic disease.
Age minimum:
2 Months
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bacterial Meningitis
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Intervention(s)
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Drug: Infusion with paracetamol
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Drug: Bolus without paracetamol
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Primary Outcome(s)
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Day 7 Mortality
[Time Frame: On day 7 from the institution of treatment]
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Secondary Outcome(s)
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Death or Any Neurological Sequelae at Discharge From Hospital.
[Time Frame: Examined at discharge from hospital. The longest hospital stay was 84 days.]
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A Change in Hearing Threshold Compared to the First Test Result
[Time Frame: Hearing thresholds obtained during any of the first three days after hospital admission were compared with hearing thresholds obtained on day seven or later, during the hospital stay. The longest hospital stay was 84 days.]
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Death or Severe Neurological Sequelae at Discharge
[Time Frame: Examined at discharge from hospital. The longest hospital stay was 84 days.]
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Death or Severe Neurological Sequelae on Day 7
[Time Frame: Examined on day 7 since institution of treatment]
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Status on the Modified Glasgow Outcome Scale
[Time Frame: Examined at discharge from hospital, except for hearing evaluations which were performed at earliest seven days since the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.]
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All Deaths During Hospital Stay
[Time Frame: The outcome was assessed each day until the patient was discharged from the hospital. The longest hospital stay was 84 days, while the last death occurred 39 days after treatment initiation.]
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Number of Participants With Deafness
[Time Frame: This outcome includes hearing thresholds determined at earliest seven days after the institution of treatment, during the hospital stay. The longest hospital stay was 84 days.]
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Death or Any Neurological Sequelae on Day 7
[Time Frame: Examined on day 7 since institution of treatment.]
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Secondary ID(s)
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INFU/PARA-BOLU/PLACE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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