NCT01540838: INFU/PARA

Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis, Especially of Pneumococcal Meningitis, in Angola.

Completed Phase 4 Results posted Last updated 22 September 2019

What this trial tests

Phase 4 trial testing Infusion with paracetamol in Bacterial Meningitis in 375 participants. Completed in 1 February 2017.

Timeline

1 February 2012

Primary endpoint
1 February 2017

1 February 2017

Quick facts

Lead sponsor	University of Helsinki
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	375
Start date	1 February 2012
Primary completion	1 February 2017
Estimated completion	1 February 2017
Sites	1 location across Angola

Drugs / interventions tested

• Infusion with paracetamol — full drug profile →
• Bolus without paracetamol — full drug profile →

Conditions studied

• Bacterial Meningitis — all drugs for Bacterial Meningitis →

Sponsor

University of Helsinki

Who can join

Adults 2 Months to 15, any sex, with Bacterial Meningitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Day 7 Mortality
  Time frame: On day 7 from the institution of treatment
  All patients who had received at least one dose of treatment and were dead on day 7 from the institution of treatment on day 1.

Sponsor's own description

The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid), combined with high-dose paracetamol orally, when both treatments are executed for the first 4 days. The series will be collected at Hospital Pediátrico David Bernardino, Luanda, Angola.

The recruitment of patients begins, the conditions permitting, in early 2012. The criteria for patient participation is a child at the age of 2 months to 15 years who presents with the symptoms and signs suggestive of bacterial meningitis, for whom a lumbar puncture is performed, and the cerebrospinal fluid analysis suggests bacterial meningitis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Extended Continuous β-Lactam Infusion With Oral Acetaminophen in Childhood Bacterial Meningitis: A Randomized, Double-blind Clinical Trial.
   Savonius O, Rugemalira E, Roine I, Cruzeiro ML, et al · · 2021 · cited 19× · PMID 32246138 · DOI 10.1093/cid/ciaa341
2. What's new in bacterial meningitis.
   Brouwer MC, Wijdicks EFM, van de Beek D. · · 2016 · cited 8× · PMID 26424682 · DOI 10.1007/s00134-015-4057-x
3. Prevalence and significance of anaemia in childhood bacterial meningitis: a secondary analysis of prospectively collected data from clinical trials in Finland, Latin America and Angola.
   Pelkonen T, Roine I, Kallio M, Jahnukainen K, et al · · 2022 · cited 4× · PMID 35288394 · DOI 10.1136/bmjopen-2021-057285
4. Non-corticosteroid adjuvant therapies for acute bacterial meningitis.
   Fisher J, Linder A, Calevo MG, Bentzer P. · · 2021 · cited 4× · PMID 34813078 · DOI 10.1002/14651858.cd013437.pub2
5. The Effect of Blood Transfusion on the Survival of Children with Both Severe Anemia and Bacterial Meningitis.
   Pelkonen T, Roine I, Cruzeiro M, Jahnukainen K, et al · · 2023 · cited 1× · PMID 36848895 · DOI 10.4269/ajtmh.22-0650
6. Importance of underweight in childhood bacterial meningitis in Finland, Latin America and Angola.
   Roine I, Kallio M, Peltola H, Pelkonen T. · · 2022 · cited 1× · PMID 35768574 · DOI 10.1038/s41598-022-15131-8
7. Clinical blindness in conjunction with childhood bacterial meningitis.
   Pelkonen T, Kallio M, Latvala T, Roine I, et al · · 2023 · PMID 37726355 · DOI 10.1038/s41598-023-41685-2
8. Auditory Steady-State Response and Hearing Impairment in Survivors of Childhood Bacterial Meningitis in Luanda, Angola.
   Karppinen M, Rugemalira E, Savonius O, Cruzeiro ML, et al · · 2023 · PMID 37109179 · DOI 10.3390/jcm12082842