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NCT ID: NCT01791049 Completed - Clinical trials for Serious Infections Due to Known or Suspected Gram-positive Pathogens

TD-1607 SAD Study in Healthy Subjects

Start date: April 2013
Phase: Phase 1
Study type: Interventional

TD-1607, administered intravenously as single doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.

NCT ID: NCT01790698 Completed - Clinical trials for Soft Tissue Infections

Systems Medicine to Study Necrotizing Soft Tissue Infections (NSTIs).

INFECT
Start date: January 2013
Phase:
Study type: Observational [Patient Registry]

This proposal focuses on highly lethal destructive tissue infections, i.e. necrotizing fasciitis and other necrotizing soft tissue infections (NSTIs), which are associated with high morbidity and mortality. The fulminant course of NSTIs demands immediate diagnosis and adequate interventions in order to salvage lives and limbs. However, diagnosis and management are difficult due to heterogeneity in clinical presentation, in co-morbidities and in microbiological aetiology. Thus, there is an urgent need for novel diagnostics and therapeutics in order to improve outcome of NSTIs. A comprehensive knowledge of diagnostic features, causative microbial agent, treatment strategies, and pathogenic mechanisms (host and bacterial disease traits and their underlying interaction network) is required for an improved diagnosis and management of NSTIs. The current proposal is designed to obtain such insights through an integrated systems biology approach in patients and experimental models. The project is based on a prospective NSTI patients cohort including a clinical registry to document clinical data and treatment strategies, combined with an isolate and biobank collection. The samples will be analyzed through advanced bioinformatics and computational modelling work flow to identify and quantify pathogen signatures and underlying networks that contribute to disease outcome. One aim is to translate clinical and systems biology data into development of novel diagnostics.

NCT ID: NCT01789905 Completed - Clinical trials for Intra-Abdominal Infections

Tygacil Drug Use Investigation

TIGER
Start date: April 15, 2013
Phase:
Study type: Observational

Secondary Data Collection Study; safety and effectiveness of Tigecycline .under Japanese medical practice

NCT ID: NCT01789658 Completed - Pain Clinical Trials

Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation

Start date: October 2012
Phase: N/A
Study type: Interventional

Oral mucositis (OM) is a common adverse effect of chemotherapy, radiotherapy and conditioning regimens before Hematopoietic Stem Cell Transplantation (HSCT). The aim of this study is to effectiveness of cryotherapy as a prophylactic treatment in children undergoing HSCT.

NCT ID: NCT01789203 Completed - BK Virus Infection Clinical Trials

Ciprofloxacin for Prevention of BK Infection

Start date: January 2013
Phase: Phase 4
Study type: Interventional

BK infection is an important cause of graft dysfunction and graft loss after renal transplantation. It has been widely accepted that emergence of BK virus correlates with the more potent immunosuppressive agents used to lower acute rejection rates. In contrast to other opportunistic infections after transplantation, for which routine prophylactic agents are administered, there is no effective agent for the prevention of BK infection. Some data, however, suggests that quinolone antibiotics such as ciprofloxacin may have activity against BK virus. This has led us to investigate whether routine, short-term ciprofloxacin administration post-transplant can lower the incidence of BK infection.

NCT ID: NCT01788371 Completed - Clinical trials for Hepatitis B Infection

Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus

Start date: March 2009
Phase: Phase 4
Study type: Interventional

To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

NCT ID: NCT01784770 Completed - Clinical trials for Legionnaires' Disease

Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

RESCUE-L
Start date: March 27, 2013
Phase: N/A
Study type: Observational

To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.

NCT ID: NCT01783379 Completed - Clinical trials for Invasive Fungal Infection

Pharmacokinetics of Micafungin in Patients Intensive Care Unit

MIMIC
Start date: January 2013
Phase:
Study type: Observational

In this trial, our goal is to determine the pharmacokinetics of micafungin in a non-selected cohort of patients with suspected or proven invasive fungal infections. Patients will receive micafungin for the period necessary to achieve clinical and / or mycological cure. An attempt will be made to have 2 PK curves, one full and one limited sampling on days 3 (n=9) and 7 (n=5). Furthermore, we will be able to determine intra-individual variability. On non-PK days, trough samples will be taken to determine the time to steady state. All samples will be taken just prior to the morning dose of micafungin. All infusion rates will be according to the SPC label information. Patients are considered to be evaluable if at least the first PK curve has been completed. Two moments of PK analysis will enable us to determine whether there is an increase over time in exposure if steady state has not been reached.

NCT ID: NCT01782495 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients

CORAL-I
Start date: February 25, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.

NCT ID: NCT01779570 Completed - Influenza Clinical Trials

Anti-inflammatory Effects of Macrolide Treatment in Influenza Lower Respiratory Tract Infections

Start date: February 2013
Phase: Phase 4
Study type: Interventional

Influenza lower respiratory tract infection (LRTI) is a major cause of morbidity and mortality worldwide. While viral replication can be suppressed by antiviral treatment, excessive inflammatory responses, which are increasingly recognized to contribute to severe influenza complications, remain unopposed. Macrolides have been used widely to treat community-acquired pneumonia, and shown to exert anti-inflammatory effects in other respiratory diseases, providing clinical benefits. In this randomized, open-label, multicenter study, we aim to investigate the anti-inflammatory effects of macrolide treatment in influenza LRTI. Its impacts on the cytokine response, viral clearance, symptoms and disease resolution will be studied. Such results may lead to the development of new therapeutic approaches against severe influenza infection, and provide better insights into disease pathogenesis.