Clinical Research Directory

Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess

Liver abscess is a common cause of presentation to medical emergency. Among the various causes of liver abscess, Amoebic liver abscess (ALA) is a frequent cause that can resemble pyogenic infections in tropical regions. Prompt diagnosis and empirical antimicrobials along with drainage or aspiration produces successful clinical recovery. Metronidazole has been the cornerstone of ALA therapy and achieves clinical cure in approximately 90% of uncomplicated cases. It is active against both luminal and tissue forms of Entamoeba histolytica, however it has relatively limited effect against the intestinal (luminal) form of parasite, so intestine may remain colonized after apparent resolution. This persistent intestinal carriage can lead to relapse or ongoing transmission. This prompts physicians to consider Diloxanide furoate as additional luminal agent for treatment of ALA along with metronidazole therapy. Diloxanide furoate is traditionally administered after metronidazole to eradicate residual intestinal infection and lower relapse rates. However, many patients receive only metronidazole because of cost, limited awareness about luminal therapy, poor adherence, or absence of local comparative evidence. Studies have shown that 30-40% of patients can have inadequate luminal parasite clearance following standard metronidazole therapy for ALA. Frequent relapses have been seen in ALA after treatment with metronidazole. As per literature, Diloxanide furoate eradicates intraluminal cysts in approximately 85-95% of patients with non-invasive amoebiasis. It remains unclear whether giving Diloxanide furoate at the same time as Metronidazole has any additional benefit compared with Metronidazole alone for patients with ALA. Theoretically, addition of diloxanide furoate could increase overall cure rate, rapid parasite clearance and reduce recurrence. However, there is no randomized controlled trial available at present to address the research question whether dual therapy with Diloxanide furoate with Metronidazole has any added benefits in ALA. So, this randomized controlled trial has been planned to evaluate whether adding Diloxanide furoate to Metronidazole treatment improves outcomes. This study will generate robust data to formulate/modify the existing guidelines of management of ALA especially in endemic areas. Research question: Whether addition of Diloxanide furoate with Metronidazole is more efficacious than Metronidazole monotherapy for treatment of amoebic liver abscess in terms of achieving better clinical cure, parasitic clearance and reduced recurrence.

Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome

In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.

Empirical Intravenous Beta-Lactam Plus Metronidazole Vs Oral Cefixime Plus Metronidazole for the Treatment of Liver Abscess

Liver abscess (LA) is potentially life threatening medical emergency requiring prompt medical intervention. The backbone of therapy is prompt empirical antimicrobial with or without percutaneous drainage/ aspiration of the abscess. The standard care for liver abscess includes empirical antimicrobials consisting both antibacterial and amoebicidal agents along with percutaneous drainage or aspiration of the collection. The antimicrobial regimen should cover against E. histolytica until microbial etiology is established or liver abscess of amoebic etiology is ruled out. But still there is no straightforward general agreement or evidence based on clinical studies regarding the standard protocol for empirical antimicrobials concerning choice, route of administration or duration of antimicrobials therapy. Most of the experts preferred intravenous antimicrobials over oral antimicrobials for the treatment of liver abscess with or without complication. But, there is no clinical trial evidence to support the rational of using intravenous antibiotics up front instead of oral antimicrobials. Recently published institutional study also suggested that empirical oral antimicrobials (Cefexime/Ciprofloxacin) were efficacious for the treatment of uncomplicated liver abscess, successfully managing around 90 % cases of liver abscess. When treating a liver abscess, the choice of antimicrobials and the administration technique must be specially tailored depending upon the existence of complications and the patient's clinical reaction. In the absence of clinical trials, the rational for using of intravenous broad spectrum antibiotics upfront instead of oral antimicrobials for the treatment of liver abscess with or without complications is doubtful and may appear injudicious contributing future rise of antimicrobial resistance. The use of intravenous antibiotics upfront may also unnecessarily lengthen hospital stays, enhance therapeutic expenditure, and raise the risk of hospital-acquired infections in patients who are capable for taking antimicrobials orally. Oral antimicrobials strategy will promote earlier discharge from the hospital and the patient can return to usual activities earlier. This study aims to provide valuable insights into the comparison and efficacy of empirical intravenous Beta-lactam antimicrobials plus Metronidazole and oral Cefixime plus Metronidazole therapy for the treatment of uncomplicated liver abscess. In this randomised controlled open label clinical trial all the patients with newly diagnosed liver abscess confirmed with radiology imaging, either by USG or CT scan, presenting at emergency or medical OPD will be screened for enrolment in the study. Following written informed consent from the participants and/or their legal guardian, those who meet the inclusion and exclusion criteria will be recruited in the study. Subsequently the participants will be randomized into either intravenous or oral antimicrobial group. The intravenous-group will receive Beta-lactam antimicrobials (i.e Piperacillin-Tazobactum 4.5g q 8 hourly or Ceftriaxone 1g q 12 hourly or Meropenem 1g q 8 hourly or Imipenem-Cilastatin 500mg q 6 hourly) Plus intravenous Metronidazole 750mg q 8 hourly for 2weeks. The oral-group will receive tablet Cefixime 200 mg q 12 hourly plus tablet Metronidazole 800 mg q 8 hourly for 2 weeks. Both the group will be provided standard care of therapy including percutaneous drainage or aspiration as per indication and will be followed up for 8 weeks. The primary outcome of clinical cure and secondary outcome of incidence of treatment failure, mortality, duration of antimicrobial therapy, recurrence, adverse drug reaction (ADR), complications will be compared between the groups.

Characteristics and Treatment Outcome of Liver Abscesses: An Observational Study

1. To assess the frequency, clinical presentation, microbiological and radiological characteristics of liver abscesses. 2. To evaluate the management plan and treatment outcome of liver abscess. 3. To study risk factors of liver abscess.

A Joint Model Based on Deep Learning to Predict Multidrug-resistant Klebsiella Pneumoniae Liver Abscess

The goal of this observational study is to train a deep learning-based model to predict multidrug-resistant Klebsiella pneumoniae liver abscess and evaluate it on a multi-center database.

Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)

Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.