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NCT ID: NCT01716585 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Chronic Hepatitis C Infection

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

NCT ID: NCT01716533 Completed - Clinical trials for Infections, Clostridium Difficile

Evaluation of the Immune Response to Clostridium Difficile in Adults With Clostridium Difficile Infection (CDI)

Start date: February 2, 2013
Phase: N/A
Study type: Interventional

This study aims to 1) evaluate the C. difficile-specific immune response in CDI patients and 2) explore the difference in immune response between the patients with CDI recurrence and those with a sustained clinical response.

NCT ID: NCT01715415 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults

Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-experienced adults.

NCT ID: NCT01714596 Completed - Wound Infection Clinical Trials

Randomized Trial to Assess PO Versus IV Antibiotics

POvIV
Start date: December 3, 2013
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery >2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other. Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2. Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2. Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2. Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.

NCT ID: NCT01714297 Completed - Infection Clinical Trials

Preoperative Versus Postoperative Start With Thromboprophylaxis in THA (Total Hip Arthroplasty)

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if there are differences in clinical events, i.e bleeding with associated morbidity, if thromboprophylaxis with LMWH (Low Molecular Weight Heparin) is initiated before or after surgery.

NCT ID: NCT01713751 Completed - Clinical trials for Surgical Site Infection

Surgical Site Infection Rates in Obese Patients After Cesarean Delivery

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

The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.

NCT ID: NCT01708889 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction

PK
Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.

NCT ID: NCT01705314 Completed - Clinical trials for Respiratory Infection

A Randomized Trial of Vitamin D to Reduce Respiratory Infection

Start date: December 2014
Phase: N/A
Study type: Interventional

The goal of this study is to assess the effectiveness of vitamin D in reducing laboratory-confirmed influenza and in reducing non-influenza viral respiratory tract infections. A cohort of children between the ages of 3 and 17 years from the Thanh Ha Commune, Thanh Liem District, Ha Nam Province, Vietnam will be randomized to either weekly vitamin D supplements or placebo. Participants who develop acute respiratory infection over a 12-month period, will be tested for influenza, the co-primary outcome, and other respiratory viruses, the other co-primary outcome, by RT-PCR.

NCT ID: NCT01704937 Completed - Clinical trials for Clostridium Difficile Infection

Fecal Microbiota Transplant (FMT) for Relapsing C. Difficile Infection in Adults and Children Using a Frozen Inoculum

Start date: November 2012
Phase: Phase 1
Study type: Interventional

Fecal microbiota transplantation (FMT) is the reconstitution of normal flora by a "stool transplant" from a healthy individual to a C. difficile-infected recipient, and has long been a successful approach to recurrent/refractory C. difficile. The purpose of this project is to generate a frozen FMT inoculum from well-screened healthy volunteer donors which can be used repeatedly, particularly in those who do not have a healthy intimate partner or other related donor. Delivery of FMT has been performed colonoscopically, by fecal retention enema, or by the nasogastric route. This study will evaluate the safety and secondarily the efficacy of a frozen inoculum administered by nasogastric tube vs administered by colonoscope. Subjects with recurrent/relapsing C. difficile infection (10 per group) will receive FMT via either: - colonoscopy - NGT The primary endpoint is assessment of safety as measured by clinical events (GI, procedural, systemic). Efficacy will be defined as a resolution of diarrhea off antibiotics for C. difficile, in the absence of a need for OTHER systemic antibiotics, i.e. resumption of a normal bowel status for the individual. Secondary efficacy endpoints include weight, subjective well-being and relative clinical improvement per standardized questionnaire, and subject qualitative assessment of, and satisfaction with, the transplant procedures. Subjects will be monitored for clinical safety by history and standard exams and the follow-up questionnaire as well as followed closely by phone and in person.

NCT ID: NCT01704755 Completed - Clinical trials for Chronic Hepatitis C Infection

A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

TURQUOISE-II
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.