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Pneumonia clinical trials

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NCT ID: NCT03153241 Completed - Pneumonia Clinical Trials

Subglottic Secretion Culture in Predicting Tracheal Microbial Flora

Start date: October 20, 2017
Phase:
Study type: Observational [Patient Registry]

Ventilator-associated pneumonia (VAP) continues to be a major cause of morbidity and mortality in the intensive care unit (ICU). Microaspiration of subglottic secretions accumulated above the endotracheal tube cuff is the primary route of bacterial entry into the lower respiratory tract.Therefore, removal of secretions from the subglottic spacehas been recommended as a preventive strategy to avoid microaspiration and VAP. In this context, whereas considerable literature exists on the use subglottic secretion drainage (SSD) in patients at risk for developing VAP, there is a lack of data on the bacterial growth in the subglottic fluid above the cuff. The primary objective of the study will be to assess the value of subglottic secretion culture in predicting microbial flora of endotracheal aspirate samplein patients admitted to our ICU and under invasive mechanical ventilation for at least 48 hours. Secondary end-point will be to estimate the predictive value of subglottic secretion culture in identifying bacterial pathogens in the sub-population of patients who will develop VAP.

NCT ID: NCT03149640 Completed - Clinical trials for Pneumonia, Ventilator-Associated

Study Comparing Inhaled Amikacin Versus Placebo to Prevent Ventilator Associated Pneumonia

AMIKINHAL
Start date: July 19, 2017
Phase: Phase 3
Study type: Interventional

The objective of the study is to prove that after the third day of invasive mechanical ventilation a three-day course of inhaled amikacin reduces the incidence of subsequent VAP. Parallel two group double blind randomized controlled clinical trial. Individual randomization, performed on day 4 of invasive mechanical ventilation, will be stratified on centre in order to account for variations in VAP prevention bundle implementation and use of systemic antibiotics the day of randomization. Patients will be treated three consecutive days with inhaled amikacin or placebo. Patients will be followed up daily in the intensive care unit for the occurrence of VAP according to international guidelines until day 28.

NCT ID: NCT03147807 Completed - Pneumonia Clinical Trials

BetaLACTA® Test for Early De-escalation of Empirical Carbapenems in Pulmonary, Urinary and Bloodstream Infections in ICU

BLUE-CarbA
Start date: October 20, 2017
Phase: N/A
Study type: Interventional

The emergence and rapid worldwide spread of Extended- Spectrum Beta-Lactamase-producing enterobacteriaceae (ESBLE) both in hospital and community, led physicians, and notably intensivists, to prescribe more carbapenems, particularly in the most fragile patients such as ICU patients. Unfortunately, the increased carbapenem consumption favored the emergence of carbapenem resistance mechanisms. Moreover, several preliminary results suggest that carbapenem could markedly impact the human intestinal microbiota, Thus, reduction of carbapenem exposure is widely desired both by national and international antibiotic plans. Therefore, the use of rapid diagnostic tests evaluating bacterial resistance to reduce inappropriate exposure to carbapenems could be a relevant solution. Due to its good diagnostic performance, the betaLACTA® test could meet these objectives. Experimental plan : Randomized, open-labeled non-inferiority clinical trial involving an in vitro diagnostic medical device (close to a phase III study), comparing two parallel groups: - Experimental group: early carbapenems de-escalation since the second dose, guided by results of the betaLACTA® test performed directly on the bacterial pellet from the microbiological sample positive on direct examination. - Control group: carbapenems de-escalation guided by definitive results of the antibiotic susceptibility test obtained 48 to 72h after microbiological sampling (reference strategy).

NCT ID: NCT03119727 Completed - Asthma Clinical Trials

Clinical Evaluation of FreeO2 (Version 4) in All Patients Receiving Oxygen

FreeO24G
Start date: January 30, 2017
Phase: N/A
Study type: Interventional

Evaluation of automatic titration of oxygen with a new version of FreeO2 (V4)

NCT ID: NCT03106909 Completed - Stroke Clinical Trials

Pulmonary CT in Pneumonia Complicating Stroke

Start date: April 10, 2017
Phase:
Study type: Observational

Pneumonia commonly complicates stroke and has a profound impact on clinical outcomes. Accurate and timely diagnosis of pneumonia complicating stroke remains a major challenge as several issues potentially confound diagnosis. Chest X-ray (CXR), a central component in the diagnostic work-up, may have limited utility in the early stages as they are often of suboptimal quality, and infrequently confirm typical diagnostic infiltrates. Blood biomarkers of the stress-immune response have received considerable attention, but interpretation has been limited by differing methodologies, including definition of pneumonia. Bacterial organisms in the oral cavity may also be of relevance as biomarkers of post-stroke pneumonia. Major challenges facing frontline clinicians are therefore whether to initiate antibiotics; if so, when and for how long. These issues have antibiotic stewardship implications for clinicians in terms of potential for under-treatment or over-treatment with antibiotics based on CXR appearances. Pulmonary Computed Tomography (CT) could be of value as a radiological reference standard when pneumonia is suspected after stroke, and enable more rigorous evaluation of the diagnostic performance of CXR (and other candidate biomarkers) to inform decision-making when pneumonia is suspected. The overall primary aim is therefore to investigate the feasibility and reliability of using pulmonary CT as a radiological reference standard for evaluating suspected pneumonia complicating stroke. The secondary aims are to explore the diagnostic accuracy of CXR and blood biomarkers (index tests) when pneumonia is suspected during hospital admission after stroke using pulmonary CT as a reference standard.

NCT ID: NCT03104075 Completed - Aging Clinical Trials

Genomics and Epigenomics of the Elderly Response to Pneumococcal Vaccines

Start date: April 17, 2017
Phase: Phase 4
Study type: Interventional

This is a prospective, single-site, randomized, then open-label study designed to develop a detailed transcriptional and epigenetic profile of the immune response to pneumococcal vaccination with conjugated and non-conjugated polysaccharide vaccines in the senescent immune system of older adults. In this study, 40 healthy adults ages 60 and older that have never received pneumococcal vaccination, will be randomized in a 1:1 ratio to receive Prevnar-13 (Pfizer), a conjugated 13-valent vaccine or Pneumovax 23 (Merck), a non-conjugated 23-valent vaccine. Following randomized assignment of vaccine, the study will be open-label. Six (6) study visits will occur over about 70 days, with an optional 7th visit for participants to receive a second vaccination with the other pneumococcal vaccine one to two years after randomization. Participants will provide blood samples for transcriptional, epigenetic and biological analyses pre- and post-vaccination.

NCT ID: NCT03101202 Completed - Clinical trials for Ventilator-Associated Pneumonia

To Compare Endotracheal Tube (ET) With Subglottic Suction Drainage and Standard ET in the Incidence of VAP

Start date: July 16, 2016
Phase: N/A
Study type: Interventional

Ventilator Associated Pneumonia (VAP) is associated with increased hospitalisation, increased health care cost and high morbidity and mortality. The incidence of VAP increases with duration of mechanical ventilation. There is limited data especially from India on the incidence of VAP and also the role of subglottic aspiration in its prevention. The aim of this study is to determine the role of subglottic suction in the incidence of VAP.

NCT ID: NCT03098524 Completed - Pneumonia Clinical Trials

Low Tidal MEChanical Ventilation Against NO Ventilation During Cardiopulmonary Bypass Heart Surgery

MECANO
Start date: May 2, 2017
Phase: N/A
Study type: Interventional

BACKGROUND. Postoperative pulmonary complications are a leading cause of morbidity and mortality after cardiac surgery. To this date, there are no recommendations regarding mechanical ventilation associated with cardiopulmonary bypass (CPB) during the surgery and anesthesiologists perform either no ventilation (noV) at all during CPB or maintain a low-tidal volume ventilation (LTV). Indirect evidence points towards better pulmonary outcomes when LTV is performed but no proper prospective trial with large inclusion of all types of cardiac surgery has been published. DESIGN. The MECANO trial is a single-center, double-blind, randomized controlled trial comparing two mechanical ventilation strategies, noV and LTV, during cardiac surgery with CPB. 1500 patients will be included for whom planned cardiac surgery with CPB is performed. They will be randomized between noV and LTV, on a 1:1 ratio. The noV group will receive no ventilation during CPB. The LTV group will receive 5 acts/minute with a tidal volume of 3 mL/kg and positive end-expiratory pressure of 5 cmH2O. Primary endpoint will be composite of overall death, early respiratory failure defined as PaO2/FiO2 ratio <200 mmHg at one-hour after arrival in the ICU, heavy oxygenation support (defined as a patient requiring either non-invasive ventilation, mechanical ventilation or high flow oxygen) at 2 days after arrival in the ICU or ventilator acquired pneumoniae defined by Center of Disease Control. Lung recruitment manoeuvers will be performed for noV and LTV groups, at the end of surgery and at the arrival in ICU with an insufflation at +30 cmH20 during 5 seconds. Secondary endpoints are those composing the primary endpoint with the addition of pneumothorax, CPB duration, quantity of postoperative bleeding, red blood cells transfusions, revision surgery requirements, length of stay in the ICU and in the hospital and total hospitalization costs. Patients will be followed until hospital discharge. SUMMARY. The MECANO trial compares a no-ventilation to a low-tidal volume strategy for mechanical ventilation during cardiac surgery with CPB, regarding a primary composite outcome including death, respiratory failure and pneumoniae.

NCT ID: NCT03094494 Completed - Clinical trials for Klebsiella Pneumonia

Double Carbapenem as Rescue Strategy for the Treatment of Carbapenemase-Producing Klebsiella Pneumoniae Infections

Start date: November 1, 2012
Phase: N/A
Study type: Observational

An observational two-center case-control study exploring the clinical impact of double-carbapenem use in a population of critically il patients with severe carbapenem-resistant Klebsiella pneumoniae infection

NCT ID: NCT03087890 Completed - HIV-1-infection Clinical Trials

Impact of Cotrimoxazole Use in Immunocompetent HIV Patients on Carriage of Antimicrobial Resistant Bacteria

CoTrimResist
Start date: March 30, 2017
Phase: Phase 4
Study type: Interventional

Cotrimoxazole preventive therapy (CPT) is recommended for prevention of morbidity and mortality due to Pneumocystis pneumonia and other infections in HIV positive patients with low immunity. Common clinical practice is to start CPT in any patient with CD4 counts below 200/µL, and, conversely, to stop CPT when immunity has been restored by antiretroviral treatment to CD4 counts above 200/µL or when viral suppression has been documented for 3 months. However, the latest WHO guidelines widely expands the indication for CPT by advocating for settings with high prevalence of malaria and bacterial infections, that all patients with HIV start CPT regardless of CD4 counts and clinical stage. Furthermore, WHO recommends these patients to continue CPT indefinitely regardless of evidence of immune restoration (The recommendation is for settings with high prevalence of malaria and bacterial infections, not for high-income countries). There is limited scientific evidence to recommend prolonged CPT, as studies have shown it is associated with modestly reduced morbidity due to pneumonia, meningitis and malaria, but no corresponding reduction in mortality. The impact of such a large increase in antibiotic use on the emergence of antimicrobial resistance has not been thoroughly considered. Our previous studies in Tanzania showed that multidrug-resistant bacteria frequently cause bloodstream infections with resultant very high case-fatality rates. As genes encoding for multiple antibiotic resistance traits are transferred by plasmids together with resistance towards cotrimoxazole, prolonged CPT will likely favor the selection of carriage of multidrug-resistant gut bacteria. The proposed randomized clinical trial is designed to assess whether prolonged CPT in HIV-positive patients results in increased fecal carriage of multi-drug resistant gut microbes or increased nasal carriage of methicillin-resistant Staphylococcus aureus (MRSA). Secondary endpoints are morbidity (clinical events, hospitalizations) and mortality. Stool specimens, nasal swabs and clinical data will be collected from persons attending voluntary counseling and testing facilities and HIV-clinics in Dar es Salaam, Tanzania. The study results may have important impact on public health in terms of assisting development of rational recommendations for CPT use, and may help prevent emerging antibiotic resistance.