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Clinical Infection clinical trials

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NCT ID: NCT05796362 Not yet recruiting - Infectious Disease Clinical Trials

A Single-Dose, Three-Way, Three-Sequence, Crossover BA Study of Azithromycin Oleogel

Start date: April 2023
Phase: Phase 1
Study type: Interventional

This is an exploratory study to describe the pharmacokinetics of the azithromycin oral and rectal oleogel in humans compared to the reference oral drug to (Zithromax) assess the impact of the novel formulation on bioavailability. The investigators will perform a randomized, balanced, single dose, three-treatment, three-period, crossover oral bioavailability study under fasted conditions to evaluate the safety and tolerability of azithromycin oleogel and compare the bioavailability of the azithromycin oleogel to the reference drug.

NCT ID: NCT05268419 Completed - Morality Clinical Trials

Efficacy and Safety of Ethanol Inhalation on COVID-19 Treatment (a Clinical Trial Study)

COVID-19
Start date: September 2, 2021
Phase: Phase 3
Study type: Interventional

Cytokine storm is the cause of many deaths in COVID -19. The antiviral in-vitro effects of ethanol with solving the fat layer and destroying the glycoprotein of coronavirus have already been established. Proven antiviral effects of ethyl alcohol on extracellular surfaces have been demonstrated by researchers. Immunological studies have shown that acute administration of ethanol can have immunomodulatory effects on innate immunity system mediated by TNFamRNA protein and mitogen-activated protein kinas and reduce cytokine storm by reducing inflammatory factors such as -TLR, TLR, TL-9, interleukin-6 and TL9. It also helps with the chemotaxis of bronchoalveolar macrophages. Other demonstrated effects of ethanol are including: inhibition of virus replication by inhibition of RNA-dependent polymerase, the bronchial dilation by relaxing their involuntary smooth muscles, sedating and relaxation of the participant, muscular analgesic effects. Ethanol administration has previously been reported for the treatment of methanol poisoning, fat embolism, prevention of preterm labor, pre-eclampsia, and pulmonary edema. The histological safety of inhalation ethanol therapy in the lungs and respiratory tracts of rabbits has been shown by Anna Castro-Balado et al. Ethanol is approved by the Food and Drug Administration. Given these effects of ethanol on virus wall destruction, inhibition of proliferation, and inhibition of immune hyperactivity, the question now is, "Can ethanol inhalation therapy be effective in controlling COVID-19?" There is no a prior knowledge of the inhalation ethanol therapy in COVID-19. This idea was first suggested and published one month after COVID-19 pandemic in Iran (February 2020). To find the answer, a clinical trial was conducted to evaluate the effectiveness of ethanol therapy on clinical state and prognosis of participants. The study was approved by the Medical University of Isfahan, research and ethics committees and is registered at https://irct.ir/trial/58201.

NCT ID: NCT03856138 Completed - Clinical trials for Inflammatory Response

Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis

Start date: December 1, 2015
Phase:
Study type: Observational

Childhood gastroenteritis establishes gastrointestinal disease and increase the economic burden, and the pediatric population is especially vulnerable to these gastrointestinal infections. The aim of this study is to evaluate the role of intestinal microbiota and their relationship with childhood gastroenteritis.

NCT ID: NCT02020213 Withdrawn - Clinical Infection Clinical Trials

Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.

Posaconazole
Start date: December 2013
Phase: Phase 4
Study type: Interventional

Invasive Aspergillus infection (IAI) occasionally occurs in immunocompromised people. Except administrating empirical anti-fungal agent, using objective parameters to support the tentative diagnosis of an IAI in order to make the anti-fungal treatment more specifically is also important. At present, serum galactomannan (GM) test is the less-invasive, non-cultural, and time-saving examination for augmenting a diagnosis of Aspergillosis. It was suggested by Infectious Disease Society of America (IDSA) 2008 as a screening and monitoring tool for Aspergillosis , and the cut-off value was adjusted to 0.5 by USA FDA . However, in clinical practice, GM seems not to have good predicted value even the sensitivity and specificity are declaimed more than 80% . Other controversial issues include the reproducibility of GM5 and the effect of piperacillin-tazobactam or other antibiotics on the accuracy of GM baseline In this study, serum GMs are examined in two conditions, one is collected for establishing a baseline and the other is collected after piperacillin-tazobactam administration. We hope to confirm the validity of GM baseline and the effect of piperacillin-tazobactam on GM value in Taiwan.