Active clinical trials for "Respiratory Tract Infections"

This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.

Premature infants (born before 34 wk) are routinely vaccinated against RSV but vaccination rate against influenza are low in spite of national programs. Study goal is to evaluate the effectiveness of short intervention during RSV prophylaxis visit, planned to educate parents about the importance of influenza vaccination.

IC-GLOSSARI (The Intensive Care GLObal Study on Severe Acute Respiratory Infection) is a multicentre, prospective, observational,14-day inception cohort study designed and conducted by the ESICM Trials Group to investigate the epidemiology and microbiology profiles of ICU-SARI, document commonly used treatment and monitoring strategies, measure current outcomes and identify potential topics for multidisciplinary studies ranging from interventional clinical trials to fundamental mechanisms of disease. The purpose of this study is to answer the following questions: What is the frequency and disease burden of SARI for ICU's worldwide? What are the aetiologies of ICU SARI? How are SARI patients diagnosed and managed in the ICU? What is the outcome from SARI in the ICU? Is there a difference in outcomes from SARI depending on the aetiology of the disease? Can we identify high-risk categories of SARI that could constitute a defined population for an interventional study?

In the past 70 years antibiotics have served as the first line of defense against infectious diseases. However, antibiotics are only effective against bacterial infections and are not the solution for infections caused by viruses such as common colds or flu. Despite their contribution to healthcare, antibiotics are currently recognized as the most misused drugs in the world with global overuse estimated at 40%-70%, mostly due to the ineffectiveness of current diagnostic solutions to distinguish between bacterial and viral infections. Antibiotics misuse often causes preventable adverse events that impact patient care and lead to the emergence of antibiotic-resistant bacteria, one of the major threats to global health today. To address these challenges, MeMed has been developing the ImmunoDx™, a novel technology that relies on the best available detection system for differentiating between viruses and bacteria - the body's own immune system. The ImmunoDx™ technology employs a simple blood test that provides the physician, within two-hours, the information he needs to decide whether to treat the patient with antibiotics or not. This technology has been tested on over 1000 patients of different ages and diseases and was found to be highly accurate and safe. The current study is a non-interventional study and the participants do not receive any investigational drug nor any experimental examination or procedure. Therefore, the collected data in this study will not affect the diagnosis, prognosis, or treatment of the participants. Participation includes the collection of a teaspoon of blood and collection of a specimen using a nasal swab. These procedures are common in the clinical practice and are widely performed and possess no significant risk. By participating in the study, the subjects impact the development of the ImmunoDx™ technology, which is expected to enable a future faster and more accurate diagnosis of infectious diseases as well as more appropriate prescription of antibiotics. This will open the way to improve treatment decisions in millions of patients around the world.

The objective of this study was to confirm if two formulations of amoxicillin and clavulanic acid (suspension) are bioequivalent. Test product was AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; Glaxo Wellcome France) and reference product AUGMENTIN 12H (400 mg Amoxicillin and 57 mg Clavulanic acid/ 5 ml; GlaxoSmithKline Mexico). The single dosage was 10 ml of suspension. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 35 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Background: Proton pump inhibitors (PPI) are effective for treating gastroesophageal reflux disease (GERD). However, they may be associated with an increased risk of gastrointestinal and respiratory tract infections. Aim: To determine if Lactobacillus GG (LGG) is an effective adjunct to PPI for reducing the risk of gastrointestinal and respiratory tract infections in children with GERD. Study design: Randomized, double-blind, placebo controlled trial.

The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent. Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension. The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years. The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.

Inappropriate antibiotic prescribing for acute respiratory infections (ARIs) persists despite decades of intervention efforts. Negative outcomes of inappropriate antibiotics include increased costs of care, adverse drug reactions, and rising prevalence of antibiotic-resistant bacteria. To address this public health problem, we apply the principles of commitment and consistency in an effort to influence clinician decision-making through the implementation of a low-cost behavioral "nudge" in the form of a simple public commitment device. Clinicians were asked to post in their exam room a signed letter indicating their commitments to reducing inappropriate antibiotic use for ARIs. Our hypothesis is that clinicians displaying the poster-sized commitment letters will decrease their inappropriate antibiotic prescribing for ARIs as compared to clinicians in the control condition (with no posted letter).

This study will use longitudinal data collection to quantify the impact of a school-based water, sanitation and hygiene (WASH) program in Mali, West Africa, on pupil absenteeism, diarrheal illness, and respiratory illness. Data will be collected from 100 intervention and 100 control schools across 4 regions in Mali. At each school research staff will randomly select 60 pupils in grades 3-6 (typically ages 7-14). Research staff will ask school directors to provide written consent for pupil participation in place of parents, a procedure that has been approved by the Malian Ministry of Education. Research staff will approach selected pupils at school to request informed oral assent for participation. The informed assent process and data collection will be conducted by local trained enumerators in the child's preferred language of French or Bambara. Oral rather than written assent was chosen due to varied literacy capabilities and to limit paperwork that identifies participants. Data collection will take place at each school once every six to eight weeks during the duration of two school years. Research staff will conduct observations of school facilities, observations of handwashing behavior of children upon leaving latrines, and an interview with the school director about WASH conditions and school enrollment information. None of these school activities collect personal data or identifiers. Data collection with pupils will be done with the same pupils every 6-8 weeks and entails a 5-minute interview asking about recent absence and symptoms of diarrhea and respiratory illness. All data collection will occur at the school, will be conducted by trained local enumerators, and will be stored on password-protected mobile data collection devices. Data will be uploaded to a password-protected server and will not contain personal identifying information. Enumerators will maintain a separate form that links pupil IDs with names, which will be kept confidential. There are no direct benefits other than contribution to general knowledge that will inform future school WASH projects. There are no risks to participation other than a small amount of class time missed by pupils, and great efforts will be made to minimize time outside of class.

This study examines the cold processes of children aged 6 to less than 14. Children will be seen by the study staff 6 days in a row during the course of their naturally-acquired colds. Nasal secretions will be examined for chemicals that the body creates during a cold. Skin cells will be collected by brushing the inside of the child's cheek with a small brush. The cells will be examined for genes that may hold control the creation of these chemicals.