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NCT ID: NCT04410263 Recruiting - ARDS Clinical Trials

Microbiota in COVID-19 Patients for Future Therapeutic and Preventive Approaches

MICRO-COV
Start date: April 9, 2020
Phase:
Study type: Observational

In light of the rapidly emerging pandemic of SARS-CoV-2 infections, the global population and health care systems are facing unprecedented challenges through the combination of transmission and the potential for severe disease. Acute respiratory distress syndrome (ARDS) has been found with unusual clinical features dominated by substantial alveolar fluid load. It is unknown whether this is primarily caused by endothelial dysfunction leading to capillary leakage or direct virus induced damage. This knowledge gap is significant because the initial balance between fluid management and circulatory support appear to be decisive. On progression of the disease, bacterial superinfection facilitated by inflammation and virus related damage, has been identified as the main factor for patient outcome, but the role of the host versus the environment microbiome remains unclear. The overarching aim of the present research proposal is to improve therapeutic strategies in critically ill patients with ARDS due to SARS-CoV-2 infection by advancing the pathophysiological understanding of this novel disease. This research thus focuses on inflammation, microcirculatory dysfunction and superinfection, aiming to elucidate risk factors (RF) for the development of severe ARDS in SARS-CoV-2 infected patients and contribute to the rationale for therapeutic strategies. The hypotheses are that (I) the primary damage to the lung in SARS-CoV-2 ARDS is mediated through an exaggerated pro-inflammatory response causing primary endothelial dysfunction, and subsequently acting two-fold on the degradation of the lung parenchyma - through the primary cytokine response, and through recruitment of the inflammatory-monocyte-lymphocyte-neutrophil axis. The pronounced inflammation and primary damage to the lung disrupts the pulmonary microbiome, leading secondarily to pulmonary superinfections. (II) Pulmonary bacterial superinfections are a significant cause of morbidity and mortality in COVID-19 patients. Pathogen colonization main Risk Factor for lower respiratory tract infections. To establish colonization, pathogens have to interact with the local microbiota (a.k.a. microbiome) and certain microbiome profiles will be more resistant to pathogen invasion. Finally, (III) Handheld devices used in clinical routine are a potential reservoir and carrier of both, SARS-CoV-2, as well as bacteria causing nosocomial pneumonia.

NCT ID: NCT04405011 Recruiting - Clinical trials for HBV/HCV Co-infection

NUC in Preventing HBV Reactivation in HCV/HBV Co-infected Patients Receiving DAA for CHC

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

HBV reactivation is common in HCV/HBV coinfected patients receiving DAA therapy for chronic hepatitis C. How to prevent HBV reactivation remains unclear. In this trial, we aim to investigate whether prophylactic nucleos(t)ide analogue (NUC) at the start of DAA could prevent HBV reactivation or not. And whether prolonged NUC prophylaxis (24 weeks) would be better than 12-week prophylaxis. This will be a three-arm, open-label, randomized, active controlled, study. Totally, 60 HBV/HCV co-infected treatment-naïve or treatment-experienced patients without decompensated liver cirrhosis will be included in this study. Group 1 patients (n=20) will receive 12-week ETV from the start of DAA therapy. Group 2 patients (n=20) will receive 24-week ETV from the start of DAA till 12 weeks after end of DAA. Group 3 patients (n=20) will not receive ETV during the period of DAA and will serve as controls. The rate of HBV reactivation and clinical reactivation will be compared among 3 groups of patients. Expected outcomes: The rate of HBV reactivation and clinical reactivation will be lower in the ETV prophylaxis group, and will be the lowest in the group receiving 24-week ETV prophylaxis.

NCT ID: NCT04382092 Completed - COVID-19 Clinical Trials

Co-infection Management in COVID-19 Critically Ill

Start date: March 23, 2020
Phase: N/A
Study type: Interventional

International guidelines suggest the administration of empirical broad-spectrum antibiotics for suspected bacterial co-infection in COVID-19 critically ill. However, data on associated respiratory infections is rare and antimicrobial stewardship interventions promoting antibiotic savings are non-existent in this context. The main objectives of the trial are: to evaluate the rate of co-infections among COVID-19 critically ill to evaluate the added value of a a rapid molecular diagnostic tool (FA-PNEU) to detect the presence of co-infecting pathogens in order to rapidly tailor the patient's antibiotic treatment

NCT ID: NCT04325438 Completed - Tuberculosis Clinical Trials

The Impact of Pharmacists' Interventions on the Quality of Life of HIV-TB Co-infection Outpatients in Indonesia

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Rationale: The co-infection of human immunodeficiency virus (HIV) and tuberculosis (TB) diseases presents further problems to patient's adherence due to high pill burden and adverse effects in the drug combination therapy. This situation is also a risk of the increase of multi-drug resistant TB and may affect the quality of life of patients. However, the prevalence of non-adherence has not been studied much in these patients in Indonesia, especially in West Java with several HIV patients who are still struggling with TB as their opportunistic infection. Pharmacist interventions in several studies have resulted in a better outcome of patients' therapy, especially in patients who need long-term adherence and compliance with drug treatment. It is hypothesized that patients' quality of life of HIV-TB co-infection patients will be improved with the intervention conducted by the pharmacist. Objective: In general, the study aimed to evaluate the utility of study participants with specific aims to describe the number of DRP and interventions applied, to describe drug concentration in selected participants (TB drugs: Rifampicin and Pyrazinamide), to compare changes of CD4+ cell counts and plasma HIV RNA (viral load) between baseline and after of intervention, to assess participants compliance and persistence to medication therapy, and descriptive analysis on the direct and indirect costs. Study design: This is a prospective, cluster-randomized study with a stepped-wedge design. Clusters correspond to participating centers. A randomly selected center is crossed-over into the intervention with calculation after the start of inclusions within 6-months follow-up in 3 different clinics in Indonesia (Bekasi City Public Hospital, Persahabatan Public Hospital Jakarta and Cipto Mangunkusumo general hospital). Intervention: Interventions are given by a pharmacist as a drug consultant is an intervention concerning the drug treatment of HAART and anti-TB. Monthly, patients will have a discussion regarding their medication and drug-related problems they experience. The pharmacist will identify drug-related problems before and during treatment and solve the problems. Main study parameters/endpoints: change from baseline utility (quality of life) at 6 months Secondary endpoints: changes from baseline in CD4+, VL, adherence, persistence at 6 months and total costs.

NCT ID: NCT04264130 Completed - Clinical trials for Schistosomiasis Haematobia

Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection

SACT
Start date: July 31, 2018
Phase: Phase 2
Study type: Interventional

Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.

NCT ID: NCT04183738 Withdrawn - Clinical trials for Cytomegalovirus Infections

Inflammation and Co-Infections in D²EFT

i2-D²EFT
Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

i2-D²EFT substudy is an observational cohort nested within the parent D²EFT study (NCT03017872). D²EFT goal is to compare the standard of care second-line antiretroviral therapy in people living with HIV whose first-line non nucleoside reverse transcriptase-based regimen failed, to two simpler regimens. Approximately 1,000 participants will be enrolled in D²EFT. Commencing a second-line ART is an important moment when the level of inflammation in participants may be elevated due to first-line ART failure; this level of inflammation should then decrease with the commencement of a new second-line treatment and would be expected to normalise by 48 weeks of second-line treatment, if successful. The investigators propose to study other factors which can influence the decrease of inflammation. The investigators hypothesise that co-infections may play a role in persistent inflammation. The key-infections of interest will be common frequent infections encounter throughout the world: Human Herpes virus 8, Epstein-Barr virus, Cytomegalovirus and Human papillomavirus, tuberculosis, malaria and other key opportunistic infections. Possible changes of level of inflammation (using the serum level of Interleukin 6) in approximately 200 participants of the D²EFT study will be investigated and measured. The hypothesis is that the presence of other infections than HIV may influence the level of inflammation in participants in therapeutic success.

NCT ID: NCT04166266 Recruiting - Clinical trials for Hepatitis B, Chronic

Observatory of Efficacy and Safety of Bulevirtide in Patients With Chronic HBV/HDV Co-infection

BuleDelta
Start date: February 19, 2020
Phase:
Study type: Observational

This is a prospective, multicentric, non comparative study, with a retrospective data collection aiming at evaluating the efficacy and safety of bulevirtide in patients with chronic HBV/HDV co-infection with severe fibrosis injuries, or moderate fibrosis injuries associated with persistent increase of ALT.

NCT ID: NCT04048850 Active, not recruiting - Hiv Clinical Trials

Zepatier in Patients With Substance Use

Start date: September 20, 2019
Phase:
Study type: Observational

The goal of this study is to assess hepatitis C virus (HCV) treatment with Zepatier (elbasvir/grazoprevir) in HCV monoinfected and human immunodeficiency virus (HIV)-HCV co-infected, HCV treatment-naïve or peginterferon/ribavirin-experienced patients with HCV genotype 1a, without baseline NS5A resistance, 1b, or 4 and substance use in urban, multidisciplinary specialty clinics.

NCT ID: NCT04032860 Active, not recruiting - HCC Clinical Trials

RCT of Different Effects of Nucleot(s)Ide Analogues on the Prognosis of HBV-HCC Patients After Curative Resection

Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

In Asia, hepatocellular carcinoma (HCC) commonly occurred in the underlying hepatitis B virus (HBV)-related liver disease.Curative therapies could improve the prognosis of HCC patients. However, tumor recurrence after curative therapy remains high with a 5-year recurrence rate >70%.The risk for HCC development is increased for patient with HBV infection,but there was no consensus about which kind of oral antiviral treatment was the best option in the prevention of HBV related HCC recurrence after curative treatment.Therefore, we conducted this study to investigate the different effects of nucleotides(TDF) and nucleosides(ETV) on the prognosis of HBV-related HCC after curative resection.

NCT ID: NCT03800407 Recruiting - Tuberculosis Clinical Trials

Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection

Start date: January 28, 2019
Phase:
Study type: Observational

Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.