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NCT ID: NCT05904223 Recruiting - Clinical trials for Respiratory Infection

Effect of IN Hospital PCR Based Assessment of Patients With Lower Respiratory Tract Infections on LEngth of Stay

INHALE
Start date: May 10, 2023
Phase: N/A
Study type: Interventional

Does the use of the BIOFIRE® FILMARRAY® Pneumonia Panel plus in hospitalized patients with lower respiratory infections lead to a reduction in length of hospital stay (LOS) and customized antibiotic treatment (higher amount of specific vs empiric treatment, shorter treatment duration, less antibiotic treatment, lower incidence of side effects) compared to the standard of care?

NCT ID: NCT05903417 Recruiting - Pleural Infection Clinical Trials

Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic

PENTAD-FT
Start date: July 10, 2023
Phase: N/A
Study type: Interventional

Parapneumonic effusions caused by an infection of the pleural membranes occur in 40-57% of cases of pneumonia. A variable percentage (10-20%) of parapneumonic effusions progresses to empyema (pus) and/or abscess formation (encapsulation). Pleural infection is associated with significant morbidity and mortality which may be as high as 20-35% in immunocompromised patients Standard treatment of these collections in adults involves antibiotic therapy, effective drainage of infected fluid and surgical intervention if conservative management fails. For parapneumonic effusions which require clearance, appropriate therapy is effective drainage via an intercostal catheter (ICC) with antibiotic therapy. The presence of fibrinous septae in the pleural space, known as loculations, may result in inadequate drainage of effusions and therefore non-resolution of infection and systemic sepsis. Without effective intercostal catheter drainage, surgical intervention (VATS or open) has usually been required to clear loculations for resolution of infection. Non-surgical treatment options to reduce the impact of adhesions and locule include (in addition to appropriate antibiotic therapy) single and multiple thoracocentesis, or single and multiple intercostal tube thoracostomies, with or without intrapleural fibrinolytic agents. Fibrinolytic agents including streptokinase, urokinase, alteplase and recombinant tissue plasminogen activator (rTPA) have been used safely and effectively intrapleurally for complicated pleural effusion and empyema. MIST 2 trial has established intrapleural therapy as the mainstay of CPEE treatment hence avoiding surgery and decreasing the length of hospitalization; however, little is known about the correct dosage needed for tPA and DNase. Dose and duration of intrapleural therapy based on MIST 2 involve multiple dosing and can be time-consuming for health care providers . Previous studies showed that complexity of treatment is a factor associated with poor adherence to a regimen. For this reason, trying to find the minimum effective dose and simplifying the regimen is essential for minimizing side effects and maximizing adherence. The review of currently available literature shows concurrent administration of tPA and DNase to be safe and effective even at lower cumulative dose Other study was carried out in May 2022 in which Modified regimen intrapleural alteplase 16 mg t-PA with 5 mg DNase for total 3 doses that administered sequentially within 24 h had been used. In this study, modified regimen of t-PA and DNase offer an alternative therapeutic option for patients that are unfit or refuse surgical intervention but persistent pleural infection. They have demonstrated similar treatment success comparable to other studies, as evidenced by improvement on pleural fluid drainage and reduction in pleural opacity on day 7 chest x-ray was approximately 50% from the baseline using intrapleural 16 mg t-PA with 5 mg DNase. The mechanism of action of t-PA and DNase in pleural cavity remain unclear. Studies suggested that IPFT may trigger the monocyte chemoattractant protein 1 (MCP-1) pathway which promote pleural fluid formation and subsequently causes a therapeutic lavage effect that increases pleural fluid drainage. Another option for intrapleural therapy may be pleural irrigation with normal saline. The idea behind is to dilute and remove bacteria, cytokines, inflammatory cells, and pro-fibrinogenic coagulation factors, which induce pleural fluid organization. Also, the mechanical process of irrigation increases pleural fluid drainage by reducing stasis and organization of the intrapleural contents . A randomised controlled pilot study in which saline pleural irrigation (three times per day for 3 days) plus best-practice management was compared with best-practice management alone was performed in patients with pleural infection requiring chest-tube drainage. The primary outcome was percentage change in computed tomography pleural fluid volume from day 0 to day 3. Patients receiving saline irrigation had a significantly greater reduction in pleural collection volume on computed tomography compared to those receiving standard care. Significantly fewer patients in the irrigation group were referred for surgery (30). However, till date there is no study done on head to head comparison between intrapleural fibrinolytic with alteplase and DNAse Versus Pleural irrigationwith normal saline.

NCT ID: NCT05899179 Recruiting - Clinical trials for Latent Tuberculosis Infection

Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and Above

Start date: August 3, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, blind, controlled trial design was used to select 240 tuberculosis (TB) patients, 120 non-tuberculous community population with other lung diseases, and 420 healthy community population without other lung diseases who met the inclusion criteria of this study. Blood supply specific gamma-interferon (T-SPOT) detection was performed first. Then, EC and Purified Protein derivation of tuberculin (TB-PPD) skin tests were performed on both arms, and the recorded results were observed. The first 24 cases of TB patients, the first 12 cases of non-tuberculous community population with other lung diseases, and the first 42 cases of healthy community population without other lung diseases were included in the trial subgroup. Physical examination, blood routine, urine routine, liver and kidney function, and electrocardiogram tests were required before and 7 days after skin test after study number assignment.

NCT ID: NCT05897541 Recruiting - Clinical trials for SARS-CoV-2 Infection

Phase 3 Study of S-217622 in Prevention of Symptomatic SARS-CoV-2 Infection

SCORPIO-PEP
Start date: June 9, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to measure the proportion of participants who are infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (positive reverse transcription polymerase chain reaction [RT-PCR] test) and have coronavirus disease 2019 (COVID-19) symptom(s) with S-217622 tablets compared with placebo tablets in participants who are household contacts of an individual with symptomatic COVID-19.

NCT ID: NCT05897203 Recruiting - Clinical trials for Acute Respiratory Infection

Clinical Trial of Natural Therapeutics for COVID-19 and Other Acute Respiratory Viral Infections

CONAT
Start date: March 3, 2023
Phase: Phase 2
Study type: Interventional

The trial "Safety, Pharmacokinetics and Preliminary Efficacy of herbal products for the treatment of acute respiratory viral infections including SARS-CoV2 in Uganda; Phase 2A Open Label Clinical Trial" is currently being implemented under the Clinical Trials of Natural therapeutics Program. The trial sample size is 510, and the participants include adults (18 years or more) who fulfill the case definitions of acute respiratory infections (ARI), test positive for one of the target respiratory viruses, are negative for TB on GeneXpert; non-pregnant/non-breast-feeding females, have no history of hypersensitivity to any of the investigational products, and have given written consent to participate in the trial. The overall objective of the trial is to assess the safety, pharmacokinetics and preliminary efficacy of TazCoV and Vidicine for the treatment of acute respiratory viral infections including (SARS-CoV2, RSV and Influenza A/B) in Uganda. Primary objectives include: 1. To determine the safety and pharmacokinetics of TAZCOV and Vidicine herbal products among adult participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza A/B 2. To determine the extent of SARS-CoV2, RSV, and Influenza A/B viral clearance among adult participants patients with acute viral respiratory infection treated using TAZCOV and Vidicine 3. To establish time-to-remission of symptoms among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine 4. To evaluate disease progression among participants patients with acute respiratory infections including those due to laboratory-confirmed SARS-CoV2, RSV and Influenza treated with TAZCOV or Vidicine The end points include: Solicited and unsolicited side effects (mild, moderate, severe, adverse and serious adverse events), days to viral clearance (RT-PCR negativity) for those with a positive viral test at enrolment and time to presenting symptom resolution. The Pharmacokinetic endpoints include: the maximum concentration of IMP in plasma [Cmax], time taken for the IMP plasma concentration to reach maximum levels [Tmax] and time taken for the concentration of the IMP in the plasma or the total amount in the body to be reduced by 50%.

NCT ID: NCT05895578 Recruiting - Clinical trials for Recurrent Urinary Tract Infection

Effect of a Probiotic on the Urinary Tract Microbiota of Participants With Recurrent Urinary Tract Infection.

PROBUTI
Start date: June 21, 2023
Phase: N/A
Study type: Interventional

Urinary tract infections (UTIs) are the most common bacterial infections in women. 50% of women experiencing at least one UTI in their lifetime with an annual prevalence of 0.5-0.7%. An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strains on the urinary tract microbiota in participants with recurrent urinary tract infection (rUTI). The study duration will be 6 and a half months, including 6 months product intake. Participants will be randomly assigned to one of the three study groups: control group with placebo administration, probiotic administration group (1 dose) and probiotic administration group (2 doses).

NCT ID: NCT05888987 Recruiting - Clinical trials for Infectious Keratitis

Use of a New Method for the Microbiological Diagnosis of Severe Corneal Infection

ABCORFILM
Start date: July 7, 2023
Phase:
Study type: Observational

Microbial keratitis is a severe and often blindness-inducing pathology which represents today the first reason for long-term hospitalization (more than 5 days) in ophthalmology. Its diagnosis is clinical and leads to an immediate hospitalization in the presence of serious criteria (Mackie classification). The entire process of microbiological diagnosis requires several days before etiological confirmation and therefore delays the initiation of targeted therapy. Recently, new PCR systems allowing the detection of 18 to 27 pathogens in 75 minutes have been developed. Their use could thus be transposed to ophthalmology by adapting the microbiological diagnostic technique to samples currently taken by swabbing the cornea. The investigators will compare their diagnosis performance versus conventional methods on patients who suffered for a microbial keratitis with severity criteria.

NCT ID: NCT05887908 Recruiting - Clinical trials for Acute Pyelonephritis

Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in Subjects With Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis

Integral-1
Start date: May 23, 2023
Phase: Phase 3
Study type: Interventional

Phase 3 study to evaluate the efficacy and safety of cefepime/nacubactam or aztreonam/nacubactam compared to imipenem/cilastatin in the treatment of complicated urinary tract infections (cUTI) or acute uncomplicated pyelonephritis (AP).

NCT ID: NCT05887037 Recruiting - Clinical trials for Central Nervous System Infections

Economic Impact of mNGS on Diagnosis of Post-neurosurgical Central Nervous System Infection

mNGS
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

The aim of the current study was to assess the economic impact of using metagenomic next-generation sequencing (mNGS) versus traditional bacterial culture directed CNSIs diagnosis and therapy in post-neurosurgical patients from Beijing Tiantan Hospital. mNGS is a relatively expensive test item, and whether it has the corresponding health economic significance in the clinical application of diagnosing intracranial infection has not been studied clearly. Therefore, the investigators hope to explore the clinical application value of mNGS detection in central nervous system infection after neurosurgery.

NCT ID: NCT05881447 Recruiting - Obesity Clinical Trials

Prevalence, Incidence and Risk Signature of Chronic Kidney Disease in Sub-Saharan Africa

RenalTWO
Start date: June 21, 2023
Phase:
Study type: Observational

Chronic kidney disease (CKD) is associated with increased cardiovascular morbidity and mortality. The prevalence of CKD is increasing worldwide and is assumed to also dramatically increase in Sub-Saharan Africa (SSA). Key shortcomings of available data on CKD in SSA are as follows: (i) Available data are based on single measurements and, therefore, cannot distinguish between harmless transient deterioration in kidney function and chronic kidney damage; (ii) Accurate information regarding renal protein loss, an important and early marker of kidney disease, is lacking; (iii) Cardiovascular risk factors for CKD, such as obesity, hypertension and diabetes, are often not searched for. Likewise non-classic potential risk factors, such as endemic infectious diseases, socioeconomic status and lifestyle have not been consistently recorded; (iv) Information to interrogate linked interaction over time between risk factors and development of CKD is unavailable. With this project, situated in a region representative of semi-rural SSA, we aim to fill this knowledge gap and (i) establish guideline conform prevalence data of CKD and its major cardiovascular risk factors, as well as (ii) prospectively define the incidence of cardiovascular- and non-classic risk factors of CKD. The data from (i) and (ii) is used to develop predictive models. A prospective cohort of 1200 individuals in a primary care facility will serve as study population. The population is representing a society in transition from rural to more urban lifestyle. In the pilot study, participants will be followed for one years and undergo the clinical and biomedical testing required to capture CKD and its classic and non-classic risk factors over time.