Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study)
Cystic FibrosisRespiratory Tract InfectionsThe purpose of this study is determine if high-dose vitamin D supplementation improves clinical outcomes related to lung function and immunity in patients with Cystic Fibrosis who are admitted to the hospital with an acute lung infection.
Safety and Efficacy of Mucinex and IR Guaifenesin the Treatment of Symptoms of Acute Upper Respiratory...
Acute Upper Respiratory Tract InfectionThe study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by immediate release (IR) guaifenesin (GGE) and do not match approved Mucinex labeling in the U.S. The purpose of this study is to determine whether Mucinex is effective and non-inferior as compared to placebo and immediate release guaifenesin in the treatment of symptoms of acute upper respiratory infections. This design was required based on EU regulatory guidance.
Oseltamivir Randomised Controlled Efficacy Trial
InfluenzaPneumonia3 moreBackground In preparation for a global influenza pandemic, there is an urgent need for representative data from populations and settings where the pandemic is most likely to arise. There are no data on oseltamivir efficacy from Asian urban slum populations concerning duration of illness and viral shedding, nor whether efficacy depends on starting treatment < 48 hours or ≥ 48 hours after illness onset. Finally, there are no data on the capacity of the drug, in such settings, to affect household and community transmission rates. Aims and Objectives This proposal aims to compare the duration of clinical illness among patients treated with oseltamivir vs placebo < 48 hours and ≥ 48 hours after illness onset. It will compare the duration of viral shedding among all treatment groups vs placebo, risk of transmission to household contacts by treatment group and whether neuraminidase inhibitor use creates resistance. Secondarily it aims to measure the effect on influenza. Design and Methods A double-blind placebo controlled clinical trial design among a population in an urban slum under current influenza disease burden surveillance will be enrolled. Infection status will be confirmed by rRT-PCR. Patients ≥ 1 year old will be randomised to < 48 hour and ≥ 48 hour treatment arms. Family members and neighbours will also be assessed by PCR and a basic reproductive number calculated (R0). Relevance These findings will address whether oseltamivir can affect illness duration and severity, affect transmission, incidence and resistance in high risk urban Asian settings where a pandemic is most likely to arise.
Trial of Amoxicillin Compared With Placebo for Pneumonia in Children Aged 2-59 Months
Acute Respiratory InfectionsPneumoniaMany children with "non-severe pneumonia" (cough and fast breathing) have neither clinical pneumonia as assessed by physicians nor pneumonia on chest radiographs. Inappropriate use of antibiotics for these cases is leading to resistant strains of bacteria in the community. Evidence shows that almost 50% of antibiotic prescription is unnecessary.As over half of antibiotic prescription for ARI are not necessary since most of these infections are viral and do not respond to antibiotic therapy which will be source of resistance in the community. To address this issue the investigators conducted this randomized, double blind placebo controlled clinical trial of oral Amoxicillin versus placebo in children with non-severe pneumonia taking into account all the necessary safety precautions for their well being. The study hypothesis was that the clinical outcome of children 2 to 59 months of age with cough and fast breathing (WHO defined non-severe pneumonia) with or without wheezing is equivalent, whether they are treated with amoxicillin or placebo.
Telithromycin in Respiratory Tract Infections
Respiratory Tract InfectionsPrimary Objectives: The primary objective of the study is to evaluate clinical efficacy i.e. to show that with respect to clinical cure rate, Ketek® (telithromycin) in the treatment of community acquired respiratory tract infections: community acquired pneumonia (CAP), acute bacterial exacerbation of chronic bronchitis (AECB) and acute sinusitis (AS), in outpatients. Secondary Objectives: The secondary objectives are to: Further assess the efficacy of Ketek® (telithromycin) by considering the rate at which additional antibacterials were prescribed to treat the primary infection; the rate of hospitalisation due to a complication of the primary infection and assessment of bacteriological data, chest X-ray and sinus X-ray if available. Evaluate safety of Ketek® (telithromycin) through Adverse Event (AE) and Serious Adverse Event (SAE) reporting
Evaluating the Effectiveness of the Acute Respiratory Infection Smart Form
Respiratory Tract InfectionsTo evaluate the effectiveness of the Acute Respiratory Infection Smart Form
Evaluation of an Algorithm to Reduce Antibiotic Prescribing for Acute Bronchitis
Acute Respiratory Tract InfectionInappropriate use of antibiotics to treat patients with acute bronchitis is a significant factor contributing to the selection of antimicrobial drug resistant pathogens, which threaten the effectiveness of available therapies to treat common community-acquired bacterial infections. A key factor driving overuse of antibiotics is inaccurate estimation of pneumonia risk among patients with acute cough illnesses. This study will use a cluster randomized trial design within the Geisinger Health System's integrated clinic network to measure the efficacy of an algorithm driven clinical decision support tool to safely reduce the frequency of unnecessary antibiotic prescriptions for adult patients with lower respiratory tract infections.
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates
Bacteria InfectionRespiratory Tract InfectionsOur hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection
PulmonarOM (Bacterial Lysates) in Respiratory Tract Infections
Respiratory Tract InfectionsPrimary - To evaluate the efficacy of Pulmonaron in the decrease of interleukin-4/interferon gamma after second period of treatment Secondary To evaluate the efficacy of Pulmonarom in the prevention of upper respiratory tract infections symptoms through patient evaluation of fever or respiratory presence after second period of treatment To evaluate loss of working or study days after second period of treatment To evaluate the safety and tolerability of Pulmonarom in the population under study
Pharmacokinetic Profiles Of Amoxicillin 2000 mg And Clavulanate 125 mg In Adolescent Patients
InfectionsRespiratory TractClinical research study to test amoxicillin and clavulanate tablet formulation for use in Acute Bacterial Sinusitis (ABS) in adolescent patients weighing at least 40 kilogram (kg) and no more than 16 years old. ABS is an acute bacterial infection of the sinus. The purpose of this study is to find out how children tolerate Augmentin XR and what happens to Augmentin XR in the body after it has been swallowed by children.