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Meningitis clinical trials

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NCT ID: NCT02274285 Completed - Tetanus Clinical Trials

DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Start date: October 2014
Phase: Phase 3
Study type: Interventional

Primary objective: - To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antigens) of investigational arm (Group A: DTaP-IPV/Hib) versus control arm (Group B: DTaP-IPV and Hib vaccines administered at separate sites), one month after the primary vaccination (all antigens). Secondary objectives: - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4) in the two study groups (Group A and Group B). - To describe the safety after each dose of each vaccine in the two study groups (Group A and Group B). - To describe immune responses against all vaccine antigens with no pre-specified hypothesis, and at all time points (pre-dose 1, post-dose 3, pre-dose 4 and post-dose 4 (Group C)

NCT ID: NCT02237365 Completed - Clinical trials for Tuberculous Meningitis

A Pilot Study of Adjunctive Aspirin for the Treatment of HIV Negative Adults With Tuberculous Meningitis

AspirinTBM
Start date: October 17, 2014
Phase: Phase 2
Study type: Interventional

Tuberculous meningitis is a severe brain infection which often causes disability and death even when treated with the best available treatment. Aspirin is a type of anti-inflammation drug which can reduce the inflammatory response in brains of patients with tuberculous meningitis, and therefore may decrease some of the most severe outcomes. This study compares the use of aspirin (at 2 different doses) versus placebo as an additional therapy to the standard treatment to see if aspirin is safe and helpful in reducing disability and death from tuberculous meningitis. Patients will be treated with aspirin or placebo for 60 days and followed up while on standard treatment for 8 months.

NCT ID: NCT02219061 Recruiting - Measles Clinical Trials

Early Waning of Maternal Measles and Meningitis C Antibodies

EWMM
Start date: May 2014
Phase: N/A
Study type: Observational

Maternal antibodies (measles and meningitis C) may wane in the first six months after birth. - Geometric mean titers(GMTs) of measles and meningitis C. - Follow-up on 0 month, 3rd month,5th month and 7th month after birth.

NCT ID: NCT02199691 Completed - Meningitis Clinical Trials

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents

Start date: July 22, 2014
Phase: Phase 2
Study type: Interventional

The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in adolescents 10 to 17 years of age in the United States (US). This study also evaluated the immunogenicity and safety of MenACYW Conjugate vaccine when given alone compared to when given concomitantly with tetanus, diphtheria, acellular pertussis (Tdap) vaccine and human papilloma virus (HPV) vaccine. Primary objective: - To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine when MenACYW Conjugate vaccine was given alone compared to those when MENVEO vaccine was given alone. Secondary objective: - To evaluate the antibody responses to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with Tdap and HPV vaccines, compared to those when it was given alone. - To evaluate the antibody responses to the antigens present in Tdap vaccine, when Tdap vaccine was given concomitantly with MenACYW Conjugate vaccine and HPV vaccine, compared to those when Tdap vaccine was given with HPV vaccine only. - To evaluate the antibody responses to the antigens present in HPV vaccine after the 3-dose series, when the first dose of HPV vaccine is given concomitantly with MenACYW Conjugate vaccine and Tdap vaccine, compared to those when the first dose of HPV vaccine is given with Tdap vaccine only. Observational objective: - To describe the safety profile of MenACYW Conjugate vaccine, compared to that of the licensed vaccine MENVEO®, and when MenACYW Conjugate vaccine was given with Tdap and HPV vaccines.

NCT ID: NCT02169882 Completed - Clinical trials for Tuberculosis, Meningeal

High-dose Rifampicin for the Treatment of Tuberculous Meningitis: a Dose-finding Study

ReDEFINe
Start date: December 1, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Tuberculous meningitis (TBM) is the most severe form of tuberculosis infection with high mortality. Current treatment regimens are not based on clinical trials. Rifampicin is a key drug for TBM, but its penetration into the brain is limited, suggesting that a higher dose may be more effective. There are several highly relevant, outstanding questions related to the appropriate dose of rifampicin for TBM, before a multicenter phase 3 trial can be performed. These are: 1. Previous phase 2a randomized clinical trial (done in the same setting as this proposed study) suggests that high doses of intravenous rifampicin (600mg, circa 13 mg/mg) for TBM is safe and associated with a survival benefit in adults. Given that i.v. rifampicin is not readily available, this needs to be confirmed using an equivalent higher oral dose of rifampicin. 2. Recent pharmacokinetic analysis of a continuation trial comparing 600 mg i.v. rifampicin with 750 mg and 900 mg oral rifampicin suggests that an even higher dose may be needed; but this has not been examined 3. Based on those previous data, there is a need to explore a longer duration of high-dose rifampicin for a subsequent phase 3 randomized clinical trial; treatment response in the investigators previous trial suggest that the optimal duration may be > 14 days. 4. There is a need to explore relevant treatment endpoints besides mortality including neurological, neuroradiological and inflammatory response.

NCT ID: NCT02136030 Recruiting - Clinical trials for Cryptococcal Meningitis

Liposomal Amphotericin B for the Treatment of Cryptococcal Meningitis

Start date: February 2011
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of liposomal amphotericin B and amphotericin B deoxycholate with or without flucytosine followed by fluconazole for the treatment of cryptococcal meningitis.

NCT ID: NCT02102256 Active, not recruiting - Clinical trials for Bilateral Cochlear Nerve Deficiency

A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

Start date: March 2014
Phase: Phase 1
Study type: Interventional

Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.

NCT ID: NCT02098525 Completed - HIV/AIDS Clinical Trials

Clinical Outcomes of Cryptococcal Meningitis Among HIV-infected Patients in the Era of Antiretroviral Therapy

Start date: November 2013
Phase: N/A
Study type: Observational

Cryptococcal meningitis is one of the most common central nervous system infections among HIV-infected patients. The outcome is generally severe. This study aims to determine long-term survival rate among HIV-infected CM patients in the era of antiretroviral therapy (ART). The secondary objectives are to clarify outcomes of CM and determine prognostic factors.

NCT ID: NCT02080559 Completed - Meningitis Clinical Trials

Investigating the Immune Response to 4CMenB in Infants

Start date: July 21, 2014
Phase: Phase 4
Study type: Interventional

This randomised, open-label, single-centre, descriptive study aims to investigate gene expression (i.e what genes are 'switched on' and 'off') following vaccination with 4CMenB and to relate this to vaccine reactions and to immune response. 160 healthy Caucasian infants aged 8-12 weeks (at time of first visit) who have not yet received their routine infant immunisations will be recruited. Participation in the study will be limited to to Caucasian infants (defined as having two Caucasian parents). This is so that baseline variability in gene expression data which is to some degree affected by ethnicity is reduced. Participants will be randomised to either a 'test' group or 'control' group depending on what 4CMenB schedule they receive, with 80 infants in each. All participants will receive the usual paediatric immunisations according to the UK national immunisation schedule. In addition, participants in the test groups will receive 4CMenB at 2, 4 and at 12 months while those in the control groups will receive the same vaccine at 5, 7 and 13 months. Blood samples will be taken from each infant at specified time points before and after vaccination to address the objectives of the study. In addition, oro-pharyneal swabs will be obtained around different vaccination timepoints to investigate the effect of 4CMenB vaccination on the oro-pharyngeal Neisseria microbiome.

NCT ID: NCT02054091 Completed - Sepsis Clinical Trials

Feeding Bovine Colostrum to Preterm Infants

PreColos
Start date: February 2014
Phase: N/A
Study type: Interventional

Feeding preterm infants is of great challenge in the NICUs. Mother's own milk is considered as the best for the digestive system followed by donor milk. Preterm infant formula is related to more feeding problems and other gut complications in these babies, such as necrotizing enterocolitis. Bovine colostrum contains higher amounts of protein, growth factors and immuno-regulatory components (e.g. immunoglobulins), which has been used in many other situations to promote health. The investigators plan to give bovine colostrum to preterm infants with birth weights between 1000 and 1800 g, or born between 27+0 and 32+6 weeks of gestational age, in order to promote feeding and intestinal health in these babies. This current study is a feasibility pilot study and the investigators hypothesized that supplementing BC to MM (if available) is safe and tolerable when used within the first 10-14 days of life in preterm infants.