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Meningitis, Bacterial clinical trials

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NCT ID: NCT01730690 Completed - Clinical trials for Meningitis, Bacterial

Bacterial Meningitis in Adults: Analysis of the Determinants of Mortality and Neurosensory Sequelae

COMBAT
Start date: March 2013
Phase: N/A
Study type: Observational

Major changes in the epidemiological characteristics of bacterial meningitis have been observed as a result of changes in behaviour, human interventions (use of antibiotics, prophylactic vaccinations), as well as poorly elucidated mechanisms responsible for epidemic outbreaks. The objective of this study is to identify the determinants of in-hospital mortality of bacterial meningitis in adults. Hypothesis : the standardized data collection concerning cases of bacterial meningitis in adults with telephone follow-up would allow analysis of the determinants of mortality and neurosensory sequelae, description of the psychosocial impact and proposal of new treatment strategies.

NCT ID: NCT01589289 Completed - Clinical trials for Cryptococcal Meningitis

Rapid Diagnostic Tests and Clinical/Laboratory Predictors of Tropical Diseases in Neurological Disorders in DRC

Nidiag-Neuro
Start date: September 2012
Phase: Phase 3
Study type: Interventional

The impact of neurological disorders is enormous worldwide, and it is increased in poor settings, due to lack of diagnosis and treatment facilities as well as delayed management. In sub-Saharan Africa, the few observational studies conducted for the past 20 years show that neurological disorders accounted for 7 to 24% of all admissions. Central nervous system (CNS) infections were suspected in one third of all patients admitted with neurological symptoms, with a specific microbial aetiology identified in half of these. Most CNS infections may be considered as "severe and treatable diseases", e.g. human African trypanosomiasis (HAT), cerebral malaria, bacterial meningitis, CNS tuberculosis etc. If left untreated, death or serious sequels occur (mortality rates were as high as 30% in the above mentioned studies), but the outcome may be favourable with timely and appropriate management. In poor settings, such conditions should be targeted in priority in the clinical decision-making process. Unfortunately, most neuro-infections present with non-specific symptoms in their early stages, leading to important diagnostic delays. Moreover, they require advanced diagnostic technology, which is not available in most tropical rural settings: here, you have to rely on clinical judgment and first-line laboratory results, whose confirming or excluding powers are limited or unknown. Several rapid diagnostic tests (RDTs) have been recently developed for conditions like malaria or HIV, but their diagnostic contribution has not been evaluated within a multi-disease approach. Thus, this research aims at improving the early diagnosis of severe and treatable neglected and non-neglected infectious diseases which present with neurological symptoms in the province of Bandundu, Democratic Republic of Congo (DRC), by combining classic clinical predictors with a panel of simple point-of-care rapid diagnostic tests. The evaluation of existing algorithms and elaboration/validation of new guidelines will be described in a subsequent protocol.

NCT ID: NCT01547715 Completed - Clinical trials for Bacterial Meningitis

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.

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: NCT01522105 Terminated - Meningitis Clinical Trials

Daptomycin in Pediatric Patients With Bacterial Meningitis

Start date: April 2012
Phase: Phase 1
Study type: Interventional

5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin administration a second lumbar puncture is performed to determine the peak concentration of daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will be measured in the plasma. The investigators anticipate that daptomycin penetrates into the cerebrospinal fluid in bactericidal concentrations

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: NCT00774631 Terminated - Clinical trials for Bacterial Meningitis

IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis

IHPOTOTAM
Start date: March 2009
Phase: Phase 4
Study type: Interventional

Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma). The usual treatment of this affection is based on the antibiotic therapy, anti-inflammatory drug and resuscitation measures in intensive care setting but the prognosis of comatose patients remains poor. Moderate hypothermia (body temperature is downed between 32 and 34°C°) made the proof of its efficiency in certain cerebral pathologies (notably the cerebral distress after cardiac arrest or oxygen lack in neonates) but was never evaluated in meningitis. In meningitis animal studies and in severe traumatic brain injury, moderate hypothermia is able to diminish cerebral oedema and brain inflammation. Thus, the objective of this study is to compare two strategies: only usual care or usual care completed by moderate hypothermia. The body temperature will be lowered between 32 and 34°C by means of a catheter placed in a big vein and connected to a machine in which circulates a cold liquid, or by means of an external cooling (ice-cold blanket, ice packs placed on the body). Whatever technique is chosen, the technique is perfectly mastered by the teams which take charge of the patients. After 48 hours, the technique of hypothermia will be suspended and body temperature will return passively and gradually to normal. The investigators believe that moderate hypothermia will improve the prognosis of the most severe patients.

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.