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Meningitis, Bacterial clinical trials

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NCT ID: NCT01540838 Completed - Clinical trials for Bacterial Meningitis

Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis

INFU/PARA
Start date: February 2012
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01431326 Completed - Hypertension Clinical Trials

Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care

PTN_POPS
Start date: November 2011
Phase:
Study type: Observational

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

NCT ID: NCT01410474 Completed - Clinical trials for Bacterial Meningitis

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

Start date: August 2011
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

NCT ID: NCT01247909 Completed - Clinical trials for Infant Bacterial Meningitis

Infant Severe Sepsis and Bacterial Meningitis in Malawi

Infaseme
Start date: April 2010
Phase: Phase 4
Study type: Interventional

This study aims to improve the outcome of infants (<2 months) with severe sepsis and meningitis at the Queen Elizabeth Central Hospital, Blantyre, Malawi. Currently WHO recommends the treatment of infant severe sepsis and bacterial meningitis with 14 to 21 day course of penicillin and gentamicin as first line. The second line treatment is cefotaxime or ceftriaxone. Severe bacterial infections are common in infants under 2 months of age and the mortality is very high (~50%). There are several reasons for this; one is that the first line antibiotics used are no longer as effective as they used to be. Bacterial resistance to the first line antibiotics has increased and some infections especially of the central nervous system may only be partly treated and not eradicated by present therapy. First line treatment is cheap and available but requires 4 injections a day, for at least 14 days, a total of 58 injections. Many mothers find this number too much and abscond. The investigators second line therapy is ceftriaxone which is also available and cheap and the advantage of being given as a daily injection. The disadvantage is that it can cause (reversible) jaundice particularly in premature babies and it must not be given with calcium products. The investigators do not give calcium to the investigators infants as the investigators cannot routinely check electrolytes. All the most common causes of bacterial meningitis in this age group in the investigators setting are sensitive to ceftriaxone. The investigators wish to undertake an open randomized trial of penicillin and gentamicin v ceftriaxone as first line treatment for infant meningitis. The investigators are able to monitor for side effects. The investigators hypothesise that the ceftriaxone arm will have 20% less deaths that the penicillin and gentamicin group.

NCT ID: NCT00619203 Completed - Clinical trials for Bacterial Meningitis

Oral Glycerol and High-Dose Rectal Paracetamol to Improve the Prognosis of Childhood Bacterial Meningitis

GLYIP
Start date: March 2008
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT00617760 Completed - Clinical trials for Neisseria Meningitidis (Bacterial Meningitis)

Safety and Immunogenicity Study of MenC-TT Vaccine (NeisVac-C) in Toddlers Previously Immunized With PCV7 (Prevenar®)

Start date: March 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study in healthy toddlers who have not previously been immunized against MenC infection and who completed their primary immunization series with PCV-7 (3 vaccinations) during infancy is to demonstrate that the concomitant administration of a single dose of MenC-TT vaccine and a PCV7 booster does not influence the immune response to the seven pneumococcal strains contained in PCV7 as compared to administration of PCV7 alone, and does not influence the immune response to the MenC-TT vaccine as compared to administration of MenC-TT vaccine alone.